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Topical anaesthetics for repair of dermal laceration

  1. Anthony Eidelman1,*,
  2. Jocelyn M Weiss2,
  3. Cristy L Baldwin3,
  4. Ikay K Enu4,
  5. Ewan D McNicol5,
  6. Daniel B Carr6

Editorial Group: Cochrane Anaesthesia, Critical and Emergency Care Group

Published Online: 15 JUN 2011

Assessed as up-to-date: 22 MAR 2011

DOI: 10.1002/14651858.CD005364.pub2


How to Cite

Eidelman A, Weiss JM, Baldwin CL, Enu IK, McNicol ED, Carr DB. Topical anaesthetics for repair of dermal laceration. Cochrane Database of Systematic Reviews 2011, Issue 6. Art. No.: CD005364. DOI: 10.1002/14651858.CD005364.pub2.

Author Information

  1. 1

    Barnes Jewish Hospital, Washington University School of Medicine, Department of Anesthesiology, Division of Pain Medicine, St Louis, MO, USA

  2. 2

    American College of Cardiology, Science and Quality Division, Washington, DC, USA

  3. 3

    University of Kansas School of Medicine-Wichita, Department of Pediatrics, Wichita, Kansas, USA

  4. 4

    University of Maryland, Department Anesthesiology, Baltimore, USA

  5. 5

    Tufts Medical Center, Departments of Anesthesiology and Pharmacy, Boston, Massachusetts, USA

  6. 6

    Tufts Medical Center, Department of Anesthesia, Boston, USA

*Anthony Eidelman, Olathe Medical Center, 20375 West 151st Street, Suite 306, Olathe, KS, 66061, USA. Anthony_eidelman@yahoo.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 15 JUN 2011

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Characteristics of included studies [ordered by study ID]
Anderson 1990

MethodsSingle-centre RCT


Participants151 patients age less then 18 years old with lacerations located on the scalp (n=31), face (n=79) or extremity (n=41)


Interventions1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 5-10 minutes (n=56),
2. Intra-dermal infiltration with lidocaine 1% (n=53),
3. Topical placebo solution applied for 5-10 minutes (n=42)


Outcomes1. Prior to laceration repair, the physician probed the wound with a 25 gauge needle to determine adequacy of initial anaesthesia.
2. The physician graded patient compliance during the suturing process on a four point scale (1-complete compliance, 2-occasional resistance, 3-frequent resistance, 4-continuous resistance).
3. Requirement of supplemental lidocaine infiltration.

Results of topical TAC versus topical placebo:
1. Adequate initial anaesthesia (topical TAC = 89% versus topical placebo = 17%, P<0.0001).
2. Physician compliance scale (1-4) ratings (complete compliance to continuous resistance) (mean score ± SD: topical TAC = 1.25 ± 0.57 versus topical placebo = 1.93 ± 0.96, P<0.002).
3. Requirement of supplemental lidocaine infiltration (topical TAC = 18% versus topical placebo = 83%, P<0.0001).

Results of topical TAC versus infiltrated local anaesthetic:
1. Adequate initial anaesthesia (topical TAC = 89% versus infiltrated local anaesthetic = 79%, P=non-significant)
2. Physician compliance scale (1-4) ratings (complete compliance to continuous resistance) (mean score ± SD: topical TAC = 1.25 ± 0.57 versus infiltrated local anaesthetic = 1.94 ± 1.12, P<0.002).
3. Requirement of supplemental lidocaine infiltration (topical TAC = 18% versus infiltrated local anaesthetic = 23%, P=non-significant).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "The last digit of the patient's medical record number was used to enter patients into either the intradermal or topical group"

Comment: Probably not done

Allocation concealment (selection bias)High riskQuote: "The last digit of the patient's medical record number was used to enter patients into either the intradermal or topical group"

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: "Individual study vials containing 5ml of TAC or placebo were prepared in the pharmacy of University of Massachusetts Medical Center following a standard protocol and assigned numbers"; "The ED staff member evaluating and suturing the patient were blind to the solution contained in the vials"

Comment: Comparisons of topical TAC and topical placebo were probably blinded. However, comparisons between lidocaine infiltration and topical TAC were probably unblinded

Incomplete outcome data (attrition bias)
All outcomes
Low risk153 eligible patients, 2 refused to participate. 151 randomized and no missing outcome data

Blackburn 1995

MethodsSingle-centre RCT


Participants35 adult and paediatric patients (minimum age of 2 years) with facial and scalp lacerations, 6cm or less in length


Interventions1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 10.4%), applied for 20 minutes (n=18)
2. Topical TLE solution (lidocaine 5% and epinephrine 1:2000), applied for 20 minutes (n=17)


Outcomes1. The patient reported discomfort using a facial effective pain scale (1-9), which consisted of nine faces with various emotional expressions. However, in a few cases the patient was too young to use the pain scale, so the physician estimated the subject's pain on the same faces scale. The study combined both the self-reported and surrogate faces pain scale scores in the final results.
2. Requirement of rescue lidocaine infiltration.
3. The study reported any acute adverse reactions directly related to the anaesthetic.

Results:
1. Faces pain scale (1-9) scores (mean score ± SD: topical LE = 3.29 ± 1.92 versus topical TAC = 2.66 ± 1.78, P=0.33).
2. Requirement for supplemental lidocaine infiltration (topical LET = 6% versus topical TAC = 6%, P=not reported).
3. No acute anaesthetic related adverse effects


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "The TAC and TLE solutions were arbitrarily assigned to a single-dose (10ml), sequentially-numbered vials by the pharmacist. The vials, with the specific contents unknown to the emergency physician, were forwarded to the ED as requested"

Comment: Probably not done

Allocation concealment (selection bias)Low riskQuote: "The solutions were made visibly identical by adding methylene blue to the TLE solution so that it matched the intrinsic blue color of TAC"

"The vials, with the specific contents unknown to the emergency physician, were forwarded to the ED as requested"

Comment: Probably done

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "The solutions were made visibly identical by adding methylene blue to the TLE solution so that it matched the intrinsic blue color of TAC"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk35 patients in study, but insufficient reporting of attrition or exclusions to permit judgment

Bonadio 1990

MethodsSingle-centre RCT


Participants55 paediatric patients with facial lacerations


Interventions1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 10-15 minutes (n=24)
2. Topical AC solution (epinephrine 1:2000, cocaine 11.8%), applied for 10-15 minutes (n=31)


Outcomes1. The physician calculated the total number of "sutures eliciting pain" using the following system. Each suture placed involved two points; an entrance and exit piercing of the wound tissue with the needle. A painful response consisted of either a verbal patient experiencing a painful sensation or a non-verbal patient beginning to cry, or crying with greater intensity. The total number of "sutures placed eliciting pain" was calculated, by dividing the total number of painful responses by two.
2. The study reported any acute adverse effects due to the anaesthetic.

Results:
1. The physician calculated the total number of "sutures eliciting pain" (topical AC = 7/103 (4%) versus topical TAC = 7/151 (7%), P=not-reported).
2. No acute anaesthetic related adverse effects


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "...as in each case an assistant randomly selected one of the two solutions for physician application..."

Comment: Probably not done

Allocation concealment (selection bias)High riskQuote: "an assistant randomly selected one of the two solutions for physician application..."

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "The managing physician was "blind" to which preparation was being administered,...the physician was informed of the solution composition only after the suturing procedure and pain scoring were completed"

Comment: Probably done, assuming the two solutions were visually identical

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk55 patients in study, but insufficient reporting of attrition or exclusions to permit judgment

Ernst 1990

MethodsRCT


Participants139 adult and paediatric patients, age greater then 5 years, with laceration of the face (n=53), scalp (n=33), extremity (n=52) or trunk (n=1), less then 5 cm in length


Interventions1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 5-10 minutes (n=69)
2. Topical cocaine solution 11.8%, applied for 5-10 minutes (n=70)


Outcomes1. The physician assessed the adequacy of initial anaesthesia by pricking the wound with a pin. If pain was elicited with pinprick, then 1% lidocaine was infiltrated and the patient was assigned to the "poor anaesthesia" group.
2. In patients who did not require infiltrated lidocaine, the physician rated the effectiveness of anaesthesia during suturing on a numerical scale (0-10). 3. The trial reported acute adverse reactions directly related to the anaesthetic.

Results:
1. Incidence of "poor anaesthesia" (topical cocaine = 20% versus topical TAC = 12%, P=not-reported)
2. Physician-rating of anaesthetic effectiveness on a numerical (0 to 10) scale (least effective to most effective) (mean scores ± SD: topical cocaine = 6.44 ± 3.48 versus topical TAC = 7.74 ± 3.03, P=0.005).
3. No acute anaesthetic related adverse effects


NotesContacted author for additional information, but no reply.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "TAC and cocaine solutions were randomly distributed with only a number from 1-150 appearing on each vial"

Comment: Unclear. The exact mechanism of randomization not described

Allocation concealment (selection bias)Unclear riskQuote: "TAC and cocaine solutions were randomly distributed with only a number from 1-150 appearing on each vial"

"The investigator was blinded as to the identity of the agent. The code was kept in the pharmacy and was available to the investigators only in case of emergency"

Comment: Unlear. There may be allocation concealment if there was a pharmacy controlled randomization process. However, this is not explicitly reported, so we decided upon unclear

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "The investigator was blinded as to the identity of the agent. The code was kept in the pharmacy and was available to the investigators only in case of emergency"

Comment: Probably done, assuming the local anaesthetic solutions are identical in colour.

Incomplete outcome data (attrition bias)
All outcomes
Low risk148 patients were enrolled and 9 patients excluded from the study before un-blinding and analysis (4 improper application, 4 patient age less then 5 and one because laceration too large). We concluded low risk of bias because the number of excluded patients was balanced between the two interventions and the reasons for exclusion unlikely to be related to pain scores during suturing.

Ernst 1995a

MethodsSingle-center RCT


Participants95 patients age 5 to 17 years with lacerations on the face (n=64) or scalp (n=31), 7cm or less in length


Interventions1. Topical LAT gel (lidocaine 4%, epinephrine 1:2000, tetracaine 0.5%), applied for 10-30 minutes (n=48)
2. Topical TAC gel (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 10-30 minutes (n=47)


Outcomes1. Patient-rated modified multi-dimensional pain scale (0-10).
2. Physician-rated modified multi-dimensional pain scale (0-10).
3. Percentage of sutures causing pain.
4. Requirement of supplemental lidocaine infiltration.
5. The trial reported acute adverse reactions directly related to the anaesthetic.

Results:
1. Patient-reported modified multi-dimensional pain scale (0-10) scores (mean ranked sum: topical LAT = 49.0 versus topical TAC = 46.9, P=0.71).
2. Physician-assigned multi-dimensional pain scale (0-10) scores (mean ranked sum: topical LAT=48.7 versus topical TAC = 47.3, P=0.80)
3. Percentage of sutures placed causing pain (mean ranked sum: topical LET = 49.57 versus topical TAC = 46.39, P=0.51).
4. Requirement supplemental lidocaine infiltration (topical LET = 4%, topical TAC = 6%, P=not-reported)
5. No acute anaesthetic related adverse effects.


NotesContacted author for additional information, but no reply.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote "Gels were randomized according to a random numbers table"

Comment: Probably done

Allocation concealment (selection bias)High riskQuote: "randomized according to a random numbers table"

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "Patients and physicians performing suturing were blinded to which gels were being used. Only the numbers 1-100 appeared on the capped syringes"

Comment: Probably done, assuming the two gels were visually identical

Incomplete outcome data (attrition bias)
All outcomes
Low risk100 patients entered into trial, but 5 patients were excluded before statistical analysis because topical anaesthesia was inadequate and lidocaine infiltration was required. Two patients in the LAT group and 3 in the TAC group were excluded. We judged low risk of bias because the number of excluded patients were balanced between the two interventions.

Ernst 1995b

MethodsSingle-centre RCT


Participants95 adult patients with lacerations of the face (n=81) or scalp (n=13), 7cm or less in length


Interventions1. Topical LAT solution (lidocaine 4%, epinephrine 1:2000, tetracaine 0.5%), applied for 10-30 minutes (n=48)
2. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 10-30 minutes (n=47)


Outcomes1. Patient-rated VAS (100 mm) pain score.
2. Physician-rated VAS (100 mm) pain score.
3. Percentage of sutures eliciting pain.

Results:
1. Patient-reported VAS (100 mm) pain scores (mean ranked sum: topical LET = 45.3 versus topical TAC = 50.8, P=0.27).
2. Physician-reported VAS scores (mean ranked sum: topical LAT = 41.6 versus topical TAC = 54.6, P=0.01).
3. Percentage of sutures causing pain (mean ranked sum: topical LET = 42.8% versus topical TAC = 53.3%, P=0.36).


NotesContacted author for additional information, but no reply.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Solutions were randomized according to a random numbers table"

Comment: Probably done

Allocation concealment (selection bias)Low riskQuote: "The solutions were prepared by a pharmacist and were available in coded sterile, capped 3ml syringes"

"Both TAC and LAT were clear solutions..."

"Patients and physicians performing wound closure were blinded"

Comment: Probably done.

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "The solutions were prepared by a pharmacist and were available in coded sterile, capped 3ml syringes with a cotton ball for application"

"Both TAC and LAT were clear solutions mixed from powders"

"Patients and physicians performing wound closure were blinded"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
High risk100 total patients enrolled but only 95 included in final data analysis. Four patients excluded because they required additional injected lidocaine (1 LAT group, 3 in TAC group) and one patient excluded because of improper data collection. We judged "no" (high risk of bias) because requirement of additional lidocaine is directly related to pain intensity during laceration repair.

Ernst 1997

MethodsSingle-centre RCT


Participants66 paediatric and adult patients, age greater then 5 years with lacerations located on the face (n=30), scalp (n=10) or extremity (n=24), 1.5-10 cm in length


Interventions1. Topical LAT gel (lidocaine 4%, epinephrine 1:2000, tetracaine 0.5%), applied for 10-20 minutes (n=33),
2. Intra-dermal infiltration with lidocaine 1%, epinephrine, buffered with 8.4% NaHCO3 (n=33)


Outcomes1. Patient-rated VAS (100 mm) pain scale scores.
2. Physician-rated VAS (100 mm) pain scale scores.
3. Requirement of supplemental lidocaine infiltration
4. Percentage of sutures placed eliciting pain.

Results:
1. Patient self-reported V AS (100 mm) pain scores (median values [interquartile range]: topical LAT = 0 [0-1.35] versus infiltrated local anaesthetic = 0 [0-0.6], P=0.48, standard deviations not reported).
2. Physician-reported VAS (100 mm) pain scores (median values [interquartile range]: topical LAT = 0 [0-0.55] versus infiltrated local anaesthetic = 0 [0-0.35], P=0.83, standard deviations not reported).
3. Percentage of sutures causing pain (topical LAT = 13% versus infiltrated local anaesthetic = 6%, P=0.28)
4. Requirement of supplemental infiltrated anaesthesia (LAT = 6% versus infiltrated anaesthetic = 0%, P=not reported).


NotesContacted author for additional information, but no reply.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The doses of anaesthetic were numbered 1-66 according to a computer generated random table of numbers prepared before the study"

Comment: Probably done

Allocation concealment (selection bias)High riskQuote: "physicians and patients were not blinded to the form of anaesthesia"

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: "Because of the obvious differences in form and application, physicians and patients were not blinded to the form of anaesthesia"

Comment: Probably not done

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk66 patients included in study, but insufficient reporting of attrition or exclusions to permit judgment

Gaufberg 2007

MethodsSingle-centre RCT


Participants100 adult patients greater then 18 years old with lacerations involving scalp (n =15), face (n = 15), lower extremity (n =13), upper extremity (n = 15 ) or hands (n = 42). Laceration length ranged from <1 cm to >5cm.


Interventions1. TLE solution (lidocaine 5%, epinephrine 0.025%), applied for 10-15 minutes for 1 to 4 sequential layered applications (n = 50)

2. Intra-dermal infiltration with lidocaine (n = 50)


Outcomes1. Patient-rated VAS (100 mm) pain scale scores

2. The amount of lidocaine to required(mg)

3. Number of applications of the topical anaesthetic

4. Difficulty with wound healing or infections

Results:

1. Patient-reported VAS (100 mm) pain scores (mean score ± SD: topical TLE = 0.16 ± 0.46 versus infiltrated lidocaine = 0.20 ± 0.49, P=0.59).

2. Amount of lidocaine required (mean score: TLE = 135mg versus infiltrated lidocaine = 124mg, P=0.90, SD not reported)

3. Number of anaesthetic applications of TLE (mean score = 2.7; 2 patients (4%) required 1 layer, 17 patients (34%) required 2 layers, 26 patients (52%) required 3 layers, 5 patients (10%) required 4 layers.

4. No patients had poor wound healing or infections


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "We performed a prospective, randomized controlled trial.."

Comment: Unclear, study reported to be randomized but method of sequence generation not described

Allocation concealment (selection bias)High riskComment: Probably not done. The interventions of topical anaesthesia versus infiltrated anaesthesia are visually different. No mechanism to conceal the intervention from patients or study personnel was described

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: "100 patient were enrolled in a randomized controlled trial..."

Comment: Probably not done, as study did not report blinding, and compared topical and infiltrated forms of anaesthesia

Incomplete outcome data (attrition bias)
All outcomes
Low risk100 enrolled patients in study and no missing outcome data or exclusions

Hegenbarth 1990

MethodsTwo-centre RCT


Participants467 patients, 18 years or younger, with dermal lacerations located on the face, scalp, extremity and trunk


Interventions1. TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%),
applied for 30 minutes (n= 262) 2. Intra-dermal infiltration with lidocaine 1% (n= 205)


OutcomesThe pain during the suturing process was not directly assessed.
1. Prior to laceration repair, the physician probed the wound with a 26-gauge needle to determine the adequacy of initial anaesthesia (adequate, inadequate or unable to access). The physician administered infiltrated anaesthetic to patients in the TAC group with "inadequate" anaesthesia.
2. The study reported any acute adverse reactions to the anaesthetic.

Results
1. Adequate initial anaesthesia for facial and scalp lacerations (topical TAC = 81% versus infiltrated local anaesthetic = 87%, P=0.005). Adequate initial anaesthesia for the extremity and trunk wound group (topical TAC = 43% versus infiltrated local anaesthetic = 89%, P<0.0001)
2. No acute anaesthetic related adverse effects


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "Randomization of anaesthetic treatment was determined by the final digit of the patients medical record number, with odd numbers receiving lidocaine and even numbers receiving TAC"

Comment: Probably not done

Allocation concealment (selection bias)High riskQuote: "Randomization of anaesthetic treatment was determined by the final digit of the patients medical record number"

"unblinded study"

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: "We conducted a prospective, randomized, unblinded study..."

Comment: Probably not done

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk467 patients included in study, but insufficient reporting of attrition or exclusions to permit judgment

Kendall 1996

MethodsSingle-centre RCT


Participants107 paediatric patients, 3-16 years old, with lacerations less then 4 cm in length, located anywhere on the body except mucous membranes or digits.


Interventions1. Topical AC solution (epinephrine 1:2000, cocaine 4.7%), applied for 10-15 minutes (n= 51)
2. Intra-dermal infiltration with lidocaine 1% (n= 51)


Outcomes1. Children less than 10 years of age rated pain during both laceration repair and anaesthetic application with the Wong-Baker faces scale. Patients 10 years or older, used a VAS (10 cm) score to rate pain during suturing and anaesthetic administration.
2. Physician-rated VAS (10 cm) pain scale scores.
3. Parent-rated VAS (10 cm) pain scale scores.
4. The parent rated the overall acceptability of the procedure.
5. The study reported any acute adverse effects to the anaesthetic

Results:
(Standard deviations were not reported)
1. Patient-rated pain scores (pooled VAS and Wong-Baker faces scores) (mean score: topical AC = 4.50 versus infiltrated local anaesthetic = 4.40, P=NS).
2. Physician-rated VAS (10 cm) pain scale scores (mean score: topical AC = 2.60 versus infiltrated local anaesthetic = 3.60, P=NS).
3. Parent-rated VAS (10 cm) pain scale scores (mean score: topical AC = 3.10 versus infiltrated local anaesthetic = 3.80, P=NS).
4. The parent's rating of overall acceptability of the procedure (topical AC = 14.5% unacceptable versus infiltrated local anaesthetic = 39% unacceptable, P<0.01).
5. No acute anaesthetic related adverse effects.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "Children presenting with an appropriate laceration were consecutively assigned to receive either conventional intradermal lignocaine or topical AC preparation"

Comment: Probably not done

Allocation concealment (selection bias)High riskQuote: "consecutively assigned to receive either conventional intradermal lignocaine or topical AC preparation"

"groups could not be blinded"

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: "The nature of the trial meant that the two groups could not be blinded"

Comment: Probably not done

Incomplete outcome data (attrition bias)
All outcomes
Low risk120 patients were enrolled but 13 excluded prior to data analysis (8 incomplete data collection, 2 received Steristrips and not sutures and 3 did not attend follow-up). We concluded low risk of bias, because reasons for exclusion unlikely to be related to pain scores during laceration repair.

Krief 2002

MethodsRCT (unclear if single or multi-centre)


Participants41 adult and paediatric patients, 5 to 23 years of age, with simple lacerations < 5cm in length


Interventions1. Topical LET gel (lidocaine, epinephrine, tetracaine), applied for 60 minutes (n=22) 2. EMLA cream (lidocaine 2.5%, prilocaine 2.5%), applied for 60 minutes (n=19)


Outcomes1. Patient-rated VAS (100 mm) pain scale scores
2. Legal guardian-rated VAS (100mm) pain scale scores (when applicable)

3. Physician-rated VAS (100 mm) pain scale scores

4. Requirement of supplemental lidocaine infiltration

Pain scores were obtained at four points in time: after irrigation, first suture or staple placement, last suture or staple placement and during supplemental infiltration of lidocaine (if applicable).

Results:
1. Patient self-reported V AS (100 mm) pain scores were not significantly different between the two anaesthetic groups (mean pain scores not provided, P > 0.05)

2. Legal guardian-reported V AS (100 mm) pain scores were not significantly different between the two groups (mean pain scores not provided, P > 0.05)

3. Physician reported V AS (100 mm) pain scores were greater in the EMLA group during irrigation (mean VAS EMLA = 21.4mm versus LET gel = 10.1mm, P=0.3) and during first suture/staple placement (mean VAS EMLA = 41.7mm versus LET gel = 14.0mm, P=0.004)

4. Requirement of supplemental infiltrated anaesthesia: 13/19 patients in the EMLA group required infiltrated lidocaine (68%) compared to 5/22 in the LET group (23%), P=0.005%


NotesTrial published as an abstract only


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "We conducted a double-blind, randomized trial..."

Comment: Unclear, as method of sequence generation not described

Allocation concealment (selection bias)Unclear riskComment: Unclear

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote: "We conducted a double-blind, randomized trial...

Comment:Unclear as reported to be double-blind, but no details provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk41 patients included in study, but insufficient reporting of attrition or exclusions to permit judgment

Kuhn 1996

MethodsSingle-centre RCT


Participants180 adult and paediatric patients, 6 years or older, with lacerations 3-7 cm in length, located on the head (n=114) or extremity (n=66)


Interventions1. Topical MAC solution (bupivacaine 0.5%, epinephrine 1:2000, cocaine 10.0%), applied for at least 10-15 minutes for head lacerations and for 30 minutes for extremity wounds (n=92)
2. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 10.0%), applied for at least 10-15 minutes for head lacerations and for 30 minutes for extremity wounds (n=88)


Outcomes1. Children less than 12 years of age rated pain during laceration repair with the Wong-Baker faces scale.
2. Patients 12 years or older, used a VAS (10 cm) score to rate pain during suturing.
3. The physician assessed the effectiveness of initial anaesthesia using pinprick.
4. The patients noted their preference for topical anaesthesia in the future.
5. The study reported any acute adverse effects to the anaesthetic

Results:
1. Children under 12 years of age used the Wong-Baker faces (1-9) scale (mean score ± SD: topical MAC = 2.35 ± .50 versus topical TAC = 2.46 ± 2.34, P=0.96).
2. Patients 12 years or older used the VAS (100 mm) pain scale (mean score ± SD: topical MAC = 6.9 ± 10.9 versus topical TAC = 12.0 ± 14.5, P=0.16). 3. Adequacy of initial anaesthesia (topical MAC = 73% versus topical TAC = 74%, P=0.87)
4. The patients preference for topical anaesthesia in the future (topical MAC = 77% versus topical TAC = 81%, P=0.42)
5. No acute anaesthetic related adverse effects


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The study was a double-blinded, randomized, prospective trial.."

Comment: Unclear as study reported to be randomized but method of sequence generation was not described

Allocation concealment (selection bias)Low riskQuote: "Solutions of MAC and modified TAC were prepared and placed in syringes marked A or B by a pharmacist not involved in study. All study participants remained blinded throughout the trial"

Comment: Probably done, assuming solutions were visually identical

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "Solutions of MAC and modified TAC were prepared and placed in syringes marked A or B by a pharmacist not involved in study. All study participants remained blinded throughout the trial"

Comment: Probably done, assuming solutions were visually identical

Incomplete outcome data (attrition bias)
All outcomes
Low risk191 patients were enrolled but 10 excluded prior to data analysis (5 less then 6 years old, two had wounds greater 5mm deep, 2 were not sutured, and 1 had a digital laceration). We concluded low risk of bias, because reasons for exclusion unlikely to be related to pain scores during laceration repair.

Pryor 1980

MethodsSingle-centre RCT


Participants158 adult and paediatric patients, range from 10 months to 53 years old (mean = 9 years old)


Interventions1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for minimum of 10 minutes
(n=82).
2. Intra-dermal infiltration with lidocaine (n=76)


Outcomes1. Patients 10 years of age or older rated anaesthetic efficacy (complete, partial or none) depending on whether they experienced pain during laceration repair.
2. Also, after completion of wound repair, the patient or parent rated the anaesthetic acceptability (excellent, good or poor).

Results:
1. Verbal rating (complete, partial or none) of anaesthetic efficacy (complete: topical TAC = 84% versus infiltrated local anaesthetic = 88%, P=not reported).
2. Anaesthetic acceptability: patients 17 years or younger preferred topical TAC (P<0.005), while there was no difference between the two anaesthetic groups in patients older then 17 years.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "A prospective study of topical TAC and lidocaine infiltration was taken with the last digit of the patients military sponsor's social security number used as the selection variable, Odd numbered patients were anaesthetised with topical TAC; even numbered patients were anaesthetised with lidocaine"

Comment: Probably not done

Allocation concealment (selection bias)High riskQuote: "the last digit of the patients military sponsor's social security number used as the selection variable"

Comment: Probably not done. Anaesthetic agents visually different and no mention of safeguards to prevent concealment of identity

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: None

Comment: Probably not blinded as the paper did not state whether patients or clinicians were blinded between the topical and infiltrated anaesthetics

Incomplete outcome data (attrition bias)
All outcomes
Low riskA total of 158 patients enrolled and no dropouts or exclusions

Resch 1998

MethodsSingle-centre RCT


Participants194 paediatric patients with lacerations of the face and scalp


Interventions1. Topical LAT solution (lidocaine 4%, epinephrine 1:2000, tetracaine 0.5%), applied for 20 minutes (n=103)
2. Topical LAT gel (lidocaine 4%, epinephrine 1:2000, tetracaine 0.5%), applied for 20 minutes (n=91)


Outcomes1. The physician assessed the adequacy of initial anaesthesia by probing the wound with a 27-gauge needle. If any pain was elicited with probing, then the anaesthetic was considered "inadequate" and infiltrated lidocaine was given.
2. At the conclusion of laceration repair, the physician rated the anaesthetic effectiveness (complete, partial or incomplete) based on painful responses during suturing.
3. The study reported acute adverse reactions directly related to the anaesthetic.

Results:
1. Adequacy of initial anaesthesia (adequate anaesthesia: LET solution = 84% versus LET gel = 82%, P>0.05).
2. Effectiveness of anaesthesia (complete anaesthesia: LET solution = 76% versus LET gel = 85%, P=0.007).
3. There were no acute anaesthetic-related adverse effects.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "A computer-generated random number table was used by a hospital pharmacy personnel to label standard amber vials from 1 to 200"

Comment: Probably done

Allocation concealment (selection bias)Low riskQuote: "hospital pharmacy personnel to label standard amber vials from 1 to 200"

"it was required that the study medication be applied by a nurse not involved in the suturing"

Comment: Probably done

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "To ensure blinding of suture personnel, in the trial, it was required that the study medication be applied by a nurse not involved in the suturing"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk200 patients enrolled and 3 withdrawn before test of initial anaesthesia because patients uncooperative or complicated laceration that did not meet inclusion criteria. Out of the 197 available for analysis, 3 data sheets inadvertently lost.

We concluded low risk of bias, because plausible effect size among missing outcomes not enough to have a clinically relevant impact on observed effect size.

Schaffer 1985

MethodsSingle-centre RCT


Participants107 paediatric patients 10 years of age or younger, with lacerations on the face (n=84) or scalp (n=23)


Interventions1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 10 minutes (n=56)
2. Topical TA solution (tetracaine 0.5%, epinephrine 1:2000), applied for 10 minutes (n=51)


Outcomes1. The physician rated the anaesthetic effectiveness (complete, partial or inadequate) based on the ability of the patient to tolerate manipulation of the wound during repair. The anaesthesia was "complete" if the patient did not cry, complain or wince during suturing. The anaesthesia was "partial" if the patient had some discomfort, but did have an avoidance reaction. "Inadequate" anaesthesia was defined as obvious discomfort with minimal manipulation of the wound.
2. Requirement of rescue lidocaine infiltration
3. The study reported any acute adverse reactions to the anaesthetic.

Results:
1. Physician-rating (complete, partial or inadequate) of anaesthetic effectiveness (complete anaesthesia: topical TA = 47.1% versus topical TAC = 75%, P<0.05).
2. Requirement of rescue lidocaine infiltration (topical TA = 27.5% versus topical TAC = 8.9%, P=0.01).
3. No acute anaesthetic related adverse effects. However, after returning home from the emergency department, 10.7% of children treated with TAC and 7.8% who received topical AC became drowsy or excitable. There was no evidence that the symptoms were causally related to the topical anesthetic and the author concluded that these were not anaesthetic induced adverse effects.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "Patients who received topical anaesthesia were randomized by alternating between A and B solutions"

Comment: Probably not done

Allocation concealment (selection bias)High riskQuote: "...randomized by alternating between A and B solutions"

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "Neither patients nor treating physicians were informed of the composition of the anaesthetic solutions"

Comment: Probably done assuming topical TAC and TA were visually identical

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk107 patients included in study, but insufficient reporting of attrition or exclusions to permit judgment

Schilling 1995

MethodsSingle-centre RCT


Participants151 patients, age 1 to 17 years old with facial (69.6%) and scalp (30.4%) lacerations


Interventions1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 15 minutes (n=73)
2. Topical LET solution (lidocaine 4%, epinephrine 0.1%, tetracaine 0.5%), applied for 15 minutes (n=78)


Outcomes1. The physician assessed the adequacy of initial anaesthesia by probing wound with a 27-gauge needle.
2. After laceration repair, the physician rated the anaesthetic effectiveness (complete, partial or incomplete). The anaesthesia was "complete" if the patient did not have a painful response to suturing. The anaesthesia was "partial" if the patient had a painful response to suturing, between 15 and 30 minutes after removal of topical solution. The anaesthesia was considered "incomplete" if the patient had a painful response, within 15 minutes after removal of the topical agent.
3. The study reported any acute adverse reactions directly related to the anaesthetic.

Results:
1. Adequacy of initial anaesthesia (topical LET = 74.4% versus topical TAC = 79.5%, P=0.46)
2. Physician-rated anaesthetic effectiveness (complete, partial, incomplete) (complete anaesthesia: topical LAT = 82.4% versus topical TAC = 75.9%, P=0.18).
3. No acute anaesthetic related adverse effects


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "...vials of the anaesthetic solutions were assigned random numbers.."

Comment: Unclear as study was reported to be randomized, but method of sequence generation not described

Allocation concealment (selection bias)Low riskQuote: "Both TAC and LET solutions are aqueous and have the same blue tint and viscosity"

"labelled to ensure appropriate blindness of suture personnel"

"A double blind topical application using 3ml of the test solutions was performed in study entry"

Comment: Probably done

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "Both TAC and LET solutions are aqueous and have the same blue tint and viscosity. Unit-dose, amber vials of the anaesthetic solutions were assigned random numbers; labelled to ensure appropriate blindness of suture personnel; and stored under refrigeration in the ED. A double blind topical application using 3ml of the test solutions was performed in study entry"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
Low risk171 patients were initially enrolled, but data analysis for only 151 subjects. Five patients excluded after consent obtained (1 sedated prior to anaesthetic administration, 2 topical anaesthetics applied inappropriate duration, 2 data sheets lost). 15 additional patients were withdrawn prior to evaluation of anaesthetic effectiveness because subjects were either uncooperative or it was discovered that the wound involved deeper tissue layers then inclusion criteria permitted. We concluded low risk of bias, because reasons for exclusion unlikely to be related to pain scores during laceration repair.

Smith 1996

MethodsSingle-centre RCT


Participants240 patients, 2 to 17 years old, with lacerations 5 cm or less
located on the face (n=134), scalp (n=57) and extremity (n=49)


Interventions1. Bupivanor (BN) solution (0.48% bupivacaine with 1:26,000 norepinephrine), applied for 20 minutes (n=30)
2. Etidonor (EN) solution (0.95% etidocaine with 1:26,000 norepinephrine), applied for 20 minutes (n=30)
3. Mepivanor (MN) solution, (1.90% mepivacaine with 1:26,000 norepinephrine), applied for 20 minutes (n=30)
4. Prilonor (PN) solution, (3.81% prilocaine with 1:26,000 norepinephrine), applied for 20 minutes (n=30)
5. TAC solution (tetracaine 1.00%, epinephrine 1:4000, cocaine 4.0%), applied for 20 minutes (n=60)
6. Infiltrated lidocaine 1% (n=60)


Outcomes1. Patients 5 years of age or older, reported discomfort using the VAS (100 mm) pain scale score.
2. Observer-reported VAS (100 mm) pain scale scores (suture technicians and research assistants).
3. Observer-reported Likert (1-7) pain scale scores (parents and suture technicians).
4. Oberver-rated (RICDRS) Restrained Infants and Children Disress Rating Scale (0 to 8) (research assistant and suture technician).
5. Suture technician-rated anaesthetic effectiveness scale.

Results (topical BN versus topical EN vs. topical MN vs. topical PN versus topical TAC versus infiltrated local anaesthetic):
(Standard deviations not reported for any of the outcomes)
1. Patient-reported VAS (100 mm) pain scores (mean scores: topical BN = 18.3 versus topical EN = 46.5 versus topical MN = 27.0 versus topical PN = 36.0 versus topical TAC = 12.0 versus infiltrated local anaesthetic = 26.3) (TAC significantly outperformed EN, P<0.05; no significant difference between any other groups).
2a. Suture technician-reported VAS (100 mm) pain scores (mean scores: topical BN = versus topical EN = versus topical MN = versus topical PN = versus topical TAC = versus infiltrated local anaesthetic = (EN significantly outperformed by BN, TAC and infiltrated anaesthetic, P<0.05; no significant difference between any other groups).
2b. Research assistant-reported VAS (100 mm) pain scores (mean scores: topical BN = versus topical EN = versus topical MN = versus topical PN = versus topical TAC = versus infiltrated local anaesthetic = ) (TAC outperformed both EN and PN, P<0.05; infiltrated anaesthetic outperformed both EN and PN, P<0.05; no significant difference between any other groups).
3a. Suture technician-reported Likert (1-7) pain scores (mean scores: topical BN = 2.05 versus topical EN = 2.6 versus topical MN = 2.4 versus topical PN = 2.1 versus topical TAC = 1.55 versus infiltrated local anaesthetic = 1.6 (TAC outperformed both EN and MN, P<0.05; infiltrated anaesthetic outperformed both EN and MN, P<0.05; no significant difference between any other groups)
3b. Parent-reported Likert (1-7) pain scores (mean scores: topical BN = 2.8 versus topical EN = 3.5 versus topical MN = 3.3 versus topical PN = 3.6 versus topical TAC = 2.11 versus infiltrated local anaesthetic = 2.33 (TAC outperformed EN, MN and PN, P<0.05; infiltrated anaesthetic outperformed EN and PN, P<0.05; no significant difference between any other groups).
4a. Suture technician-reported RICDRS (0-8) (mean scores: topical BN = 2.5 versus topical EN = 3.6 versus topical MN = 2.3 versus topical PN = 2.5 versus topical TAC = 1.4 versus infiltrated local anaesthetic = 1.63 (TAC outperformed EN, P<0.05; infiltrated anaesthetic outperformed EN, P<0.05; no significant difference between any other groups).
4b. Research assistant-reported RICDRS (0-8) (mean scores: topical BN = 2.4 versus topical EN = 3.1 versus topical MN = 2.7 versus topical PN = 2.9 versus topical TAC = 1.6 versus infiltrated local anaesthetic = 1.8 (TAC outperformed both EN and PN, P<0.05; infiltrated anaesthetic outperformed EN, P<0.05; no significant difference between any other groups).
5. Anaesthetic effectiveness scale (scores not reported) (TAC outperformed EN and MN, P<0.05; infiltrated anaesthetic outperformed BN, EN, MN, PN, P<0.05; no significant difference between any other groups).


NotesContacted author to request additional study data, author replied but unable to provide the lacking information. High risk of bias for local anaesthetic versus topical anaesthetic, as this comparison not blinded. However,unclear risk of bias in three domains for comparisons of different topical anaesthetics, because appropriately blinded.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Study patients were assigned to one of six anaesthetic treatment groups using block randomization"

Comment: Unclear, as exact method of selecting the blocks is not reported

Allocation concealment (selection bias)Unclear riskComment: Unclear

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "Comparisons among the five topical preparations were double blinded. Because lidocaine was given as an injection, its identity was not blinded"; "Anesthetics were prepared in advance by Children's Hospital pharmacy, sealed in envelopes labelled with a study identification number, and stored in a locked cabinet in the emergency department"

Comment: Probably blinded between comparisons of different topical agents, but probably not blinded between infiltrated lidocaine and topical anaesthetic

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk240 patients included in study, but insufficient reporting of attrition or exclusions to permit judgment

Smith 1997a

MethodsSingle-centre RCT


Participants71 patients, 2-16 years old, with lacerations, 5 cm or less in length located on the face (n=43) or scalp (n=28), 5 cm or less in length


Interventions1. Mepivanor (MN) solution, (mepivacaine 2%, norepinephrine 1:100,000), applied for 20 minutes (n=24)
2. TAC solution (tetracaine 1.0%, epinephrine 1:4000, cocaine 4.0%), applied for 20 minutes (n=24)
3. Intra-dermal infiltration with lidocaine 1% (n=23)


Outcomes1. Observer-reported VAS (100 mm) pain scales scores (suture technicians, research assistants and video-tape reviewers).
2. Observer-reported Lickert (1-7) pain scale scores (parent, suture technicians).
3. Requirement for supplemental lidocaine infiltration

Results (topical MN vs. topical TAC vs. infiltrated local anaesthetic):
1a. Suture technician-reported VAS (100 mm) pain scores (mean score ± SD: topical MN = 7.1 ± 12.5 versus topical TAC = 2.0 ± 2.7 versus infiltrated anaesthetic = 1.8 ± 4.0). (Both topical TAC and infiltrated anaesthetic outperformed topical MN, P=0.003)
1b. Research assistant-reported VAS (100 mm) pain scores (mean score ± SD: topical MN = 14.8 ± 19.5 versus topical TAC = 4.7 ± 8.5 versus infiltrated anaesthetic = 3.0 ± 4.0). (Both topical TAC and infiltrated anaesthetic outperformed topical MN, P=0.0003)
1c. Video-tape reviewer-reported VAS (100 mm) pain scores (mean score ± SD: topical MN = 5.0 ± 12.5 versus topical TAC = 5.25 ± 16.42 versus infiltrated anaesthetic = 2.0 ± 5.9). (No reported difference between groups, P>0.05).
2a. Suture technician-reported Likert (1-7) pain scores (mean score ± SD: topical MN = 2.2 ± 1.4 versus topical TAC = 1.7 ± 0.9 versus infiltrated anaesthetic = 1.6 ± 1.0). (No reported difference between groups, P=0.18).
2b. Parent-reported Likert (1-7) pain scores (mean score ± SD: topical MN = 3.7 ± 1.9 versus topical TAC = 2.4 ± 1.8 versus infiltrated anaesthetic = 2.4 ± 1.6). (Both topical TAC and infiltrated anaesthetic outperformed topical MN, P=0.02)
3. Requirement supplemental lidocaine infiltration (topical MN = 37.5% versus topical TAC = 8.3%, P=0.04).


NotesObtained additional study data by directly contacting author.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Enrolled patients were assigned to receive one of three anesthetic preparations by block randomization"

Comment: Unclear, as exact method of selecting the blocks not described in study

Allocation concealment (selection bias)Unclear riskComment: unclear

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "Comparions between topical mepivonor and TAC were blinded to all observers. Since lidocaine was given as an injection, its identity was not blinded to those present for the procedure. However, after the anaesthetic was administered, suturing procedures were videotaped. These videotapes were later reviewed by an observer who was completely blinded to which local anaesthetic the patient had received"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk71 patients included in study, but insufficient reporting of attrition or exclusions to permit judgment

Smith 1997b

MethodsSingle-centre RCT


Participants240 patients, 1-18 years, with lacerations less then or equal to 5 cm in length, located on the face (51%), scalp (30%), extremity (18%) or other site (1%)


Interventions1. Prilophen (PP) solution (prilocaine 3.56%, phenylephrine 0.99%), applied for 20 minutes, (n=60)
2. Tetraphen (TP) solution (tetracaine 1.0%, phenylephrine 5.0%), applied for 20 minutes, (n=60)
3. Tetralidophen (TLP) solution (tetracaine 1.0%, lidocaine 1.0%, phenylephrine 2.5%), applied for 20 minutes, (n=60)
4. TAC solution (tetracaine 1.0%, epinephrine 1:4000, cocaine 4.0%), applied for 20 minutes, (n=60)


Outcomes1. Patients 5 years or older reported VAS (100 mm) pain scale scores.
2. Oberver-reported VAS (100 mm) pain scale scores (suture technicians, research assistants and parents).
3. Oberver-reported Likert (1-7) pain scale scores (suture technicians, research assistants and parents).
4. Suture technicians-rated the anaesthetic effectiveness (complete, partial or no anaesthesia).

Results (topical PP vs. topical TP vs. topical TLP vs. topical TAC):
1. Patient self-reported VAS (100 mm) pain scores (mean score ± SD: topical PP = 29.0 ± 43.4 versus topical TP = 24.2 ± 37.2 versus
topical TLP = 30.6 ± 40.3 versus topical TAC = 17.6 ± 34.1). (No reported difference between groups, P=0.5)
2a. Suture technician-rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 7.4 ± 16.0 versus topical TP = 5.1 ± 12.6 versus
topical TLP = 6.0 ± 13.5 versus topical TAC = 3.5 ± 11.8). (topical TAC performed significantly better then topical PP, reported P=0.04)
2b. Research assistant- rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 1.6 ± 2.6 versus topical TP = 1.9 ± 4.2 versus
topical TLP = 1.3 ± 1.7 versus topical TAC = 0.9 ± 1.7). (No reported difference between groups, P=0.09).
2c. Parent-rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 20.0 ± 21.7 versus topical TP = 20.2 ± 21.7 versus
topical TLP = 18.2 ± 18.6 versus topical TAC = 14.0 ± 18.6). (No reported difference between groups, P=0.09).
3a. Suture technician-reported Likert (1-7) pain scores (median score: topical PP = 2.0 versus topical TP = 1.0 versus topical TLP = 2.0 versus topical TAC = 1.0). (topical TAC performed significantly better then either topical PP or topical TLP, P=0.01)
3b. Research assistant-reported Likert (1-7) pain scores (median score: topical PP = 2.0 versus topical TP = 1.0 versus topical TLP = 2.0 versus topical TAC = 1.0). (topical TAC performed significantly better then either topical PP or topical TLP, P=0.03)
3c. Parent-reported Likert (1-7) pain scores (median score: topical PP = 2.0 versus topical TP = 2.0 versus topical TLP = 2.0 versus topical TAC = 2.0). (No reported difference between any of the groups, P=0.06)
4. Anaesthetic effectiveness (complete anaesthesia: topical PP = 63% versus topical TP = 67% versus topical TLP = 65% versus topical TAC = 80%). (No reported difference between any of the groups, P =.18).


NotesContacted author to request additional study data, author replied but unable to provide the lacking information.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly assigned to one of four anesthetic treatment groups.."

Comment: Unclear as study reported to be randomized but method of sequence generation not described

Allocation concealment (selection bias)Unclear riskComment: Unclear

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote: "Using a prospective, randomized, double-blind design..."

"Anesthetic agents were sealed in envelopes labelled with a study identification number and stored in a locked cabinet in the emergency department".

Comment: Probably done, assuming topical solutions visually identical.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk240 patients included in study, but insufficient reporting of attrition or exclusions to permit judgment

Smith 1998a

MethodsSingle-centre RCT


Participants180 patients, age 1-18 years old, with lacerations 5cm or less, located on the face (n=76), scalp (n=59), extremity (n=43) or other (n=2)


Interventions1. Prilophen (PP) solution (3.56% prilocaine, 0.10% phenylephrine) applied for 20 minutes (n=60)
2. Bupivaphen (BP) solution (0.67% bupivacaine, 0.10% phenylephrine) applied for 20 minutes (n=60)
3. TAC solution (tetracaine 1.0%, epinephrine 1:4000, cocaine 4.0%) applied for 20 minutes (n=60)


Outcomes1. Patients 5 years and older self-reported pain using a VAS (100 mm) scale
2. Observer-reported VAS (100 mm) pain scale scores (suture technicians, research assistants and parents)

Results (topical PP vs. topical BP vs. topical TAC):
1. Patient self-reported VAS (100 mm) pain scores (mean score ± SD: topical PP = 21.0 ± 28.0 versus topical BP = 41.0 ± 35.0 versus topical TAC = 18.0 ± 24.0). (No difference reported between groups, P=0.07)
2a. Suture technician-rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 3.8 ± 8.5 versus topical BP = 5.0 ± 9.0 versus topical TAC = 1.5 ± 3.0). (topical TAC outperformed topical BP, P=0.006; no difference between TAC and PP; no difference between BP and PP)
2b. Research assistant- rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 3.0 ± 6.0 versus topical BP = 3.8 ± 4.9 versus topical TAC = 1.4 ± 2.1). (topical TAC outperformed topical BP, P=0.002; no difference between TAC and PP; no difference between BP and PP)
2c. Parent-rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 24.0 ± 24.5 versus topical BP = 29.0 ± 28.0 versus topical TAC = 17.0 ± 20.5). (TAC outperformed BP, P=0.03; no difference between TAC and PP; no difference between BP and PP)


NotesContacted author to request additional study data, author replied but unable to provide the lacking information.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "68 patients were assigned to each of the three anaesthetic treatment groups using block randomization"

Comment: Unclear, as exact method of selecting the blocks not reported

Allocation concealment (selection bias)Unclear riskComment: Unclear

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote: "Using a prospective, randomized, double-blind design..."

"Anesthetics were sealed in envelopes labelled with a study identification number and stored in a locked cabinet in the ED"

Comment: Probably done, assuming solutions visually identical

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk180 patients included in study, but insufficient reporting of attrition or exclusions to permit judgment

Vinci 1996

MethodsSingle-centre RCT


Participants156 patients, 3 to 18 years old with lacerations on the face/scalp (n= 102), extremity (n=47), trunk (n=7)


Interventions1. TAC 1 solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%) applied for 15-30 minutes, (n=49)
2. TAC 2 solution (tetracaine 1.0%, epinephrine 1:2000, cocaine 4.0%), applied for 15-30 minutes, (n=49)
3. TAC 3 solution (tetracaine 1.0%, cocaine 4.0%), applied for 15-30 minutes, (n=58)


Outcomes1. Physician-rating of anaesthetic effectiveness (complete, partial or no anaesthesia). The anaesthesia was "complete" if the patient did not move, flinch or grimace during repair. The anaesthesia was "partial" if the patient complained of pain, moved or grimaced. If supplemental lidocaine infiltration was required then there was "no anaesthesia".
2. Requirement for a second application of topical anaesthetic.
3. Requirement for supplemental lidocaine infiltration.
4. The study reported acute adverse effects directly due to the anaesthetic.

Results for TAC 1 (standard formulation) vs. TAC 3 (tetracaine-cocaine):
1. Incidence of complete anaesthesia (topical TAC 1 = 73% versus topical TAC 3 = 28%, P<0.001).
2. Requirement for a second dose of topical anaesthetic (topical TAC 1 = 30% versus topical TAC 3 = 66%, P<0.003).
3. Requirement for supplemental lidocaine infiltration (topical TAC 1 = 6% versus topical TAC 3 = 9%, P=not reported).

Results for TAC 2 (higher concentration tetracaine, lower concentration cocaine) vs. TAC 3 (tetracaine-cocaine):
1. Incidence of complete anaesthesia (topical TAC 2 = 63% versus topical TAC 3 = 28%, P<0.001).
2. Requirement for a second dose of topical anaesthetic (topical TAC 2 = 46% versus topical TAC 3 = 66%, P<0.003).
3. Requirement for supplemental lidocaine infiltration (topical TAC 2 = 2% versus topical TAC 3 = 9%, P=not reported).
4. A single paediatric patient developed an erythematous rash one day after application of standard topical TAC.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The solutions were batched in lots of 10 doses to limit expiration of the study drugs. The order of batching was generated using a standard table of random numbers"

Comment: Probably done

Allocation concealment (selection bias)High riskQuote: "The order of batching was generated using a standard table of random numbers"

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote: "...we conducted a randomized, prospective, double-blind, clinical trial comparing three different formulations of cocaine-containing topical anaesthetics"

Unclear: In the introduction section reported to be a double-blind study, but no details provided in methods or any other sections.

Incomplete outcome data (attrition bias)
All outcomes
Low riskA total of 165 patients randomized in study and no missing outcome data or exclusions

White 1986

MethodsSingle-centre RCT


Participants68 adult patients, older then 18 years old with lacerations less then 5cm in length, located on the face (n=22), or non-facial (n=46)


Interventions1. TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 10.0%), applied for 5-10 minutes (n=36)
2. Tetracaine solution (tetracaine 0.5%), applied for 5-10 minutes (n=32)


Outcomes1. Patient-rated numerical pain scale score (0-10).
2. Requirement of supplemental lidocaine infiltration.

Results:
1. Patient-rated numerical pain scale (0-10) score (mean pain scores: topical tetracaine = 5.6 versus topical TAC = 3.53, P<0.05, standard deviations not reported).
2. Requirement rescue lidocaine infiltration (topical tetracaine = 59% versus topical TAC = 36%, P=not reported).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "Prior to delivery to the emergency department, the TAC and tetracaine solutions were assigned odd or even numbers"; "Randomization was achieved by matching the vials to the odd or even numbers at the end of the hospital number"

Comment: Probably not done

Allocation concealment (selection bias)High riskQuote: "Randomization was achieved by matching the vials to the odd or even numbers at the end of the hospital number"

Comment: Probably not done

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: " Only the pharmacist preparing the solutions knew which vials contained tetracaine and which contained TAC"

Comment: Probably done, assuming visually identical solutions

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk68 patients participated in the study. It is not clear whether this was the same number that were randomized or whether there was any withdrawn.

Zempsky 1997

MethodsSingle-centre RCT


Participants32 patients, 5 to 18 years old, with lacerations less then 5 cm long, located on the extremity (n=32)


Interventions1. EMLA cream (lidocaine 2.5%, prilocaine 2.5%), applied for maximum 60 minutes (n=16)
2. TAC solution (formulation not reported by study), applied maximum of 30 minutes (n=16).


Outcomes1. Patient-rated VAS (100 mm) pain scores.
2. Observer-rated VAS (100 mm) pain scores by the suturing physician and parent.
3. Requirement for supplemental lidocaine infiltration.

Results:
1. Patient-rated VAS (100 mm) pain scores (mean score ± SD: EMLA = 46.0 ± 26.0 versus topical TAC = 40.0 ± 25.0, P=0.50).
2. Parent-rated VAS (100 mm) pain scores (mean score ± SD: EMLA = 42.0 ± 15.0 versus topical TAC = 43.0 ± 25.0, P=1.0) and physician-rated VAS (100 mm) pain scores (mean score ± SD: EMLA = 30.0 ± 16.0 versus topical TAC = 26.0 ± 14.0, P=0.45).
3. Requirement for supplemental lidocaine infiltration (EMLA = 15% versus topical TAC = 55%, P=0.03).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "...the patient was randomized into one of the two study groups by a table of random number"

Comment: Probably done

Allocation concealment (selection bias)High riskQuote: "...the patient was randomized into one of the two study groups by a table of random number"

Comment: Porbably not done

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "The sutures, who were blinded to the patients' assignments, were not investigators in the study and were not allowed to see the patient until the anaesthetic had been removed and the wound irrigated"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
Low riskA total of 32 patients enrolled and no dropouts or exclusions

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Adler 1998This study compared topical lidocaine-epinephrine-tetracaine (LET) only with placebo. There was no comparison with infiltrated local anaesthetics or other topical anaesthetics.

Adriansson 2004Topical xylocaine was not the primary anaesthetic for repair of the dermal injury. Instead the topical anaesthetic was only a pre-treatment prior to infiltration with local anaesthetic.

Bartfield 1995The topical agent was not the primary anaesthetic for repair of the dermal injury. The topical agent was only a pre-treatment prior to infiltration with local anaesthetic.

Bartfield 1996The topical agent was not the primary anaesthetic for repair of the dermal injury. The topical agent was only a pre-treatment prior to infiltration with local anaesthetic.

Bass 1990Not a randomized controlled trial. There are no controls and all patients received topical lignocaine-adrenaline-cocaine.

Bonadio 1988aNot a randomized controlled trial. There are no controls and all patients received topical TAC.

Bonadio 1988bNot a randomized controlled trial. There are no controls and all patients received topical TAC.

Bonadio 1992Not a randomized controlled trial. There are no controls and all patients received TAC gel.

Bonadio 1996The study evaluated patients with lacerations located on mucous membranes.

Chale 2006Compared local anaesthetic with digital anaesthesia. All laceration were pre-treated with topical anaesthetic but this was only too reduce pain from local anaesthetic infiltration. Topical anaesthesia was not used to reduce pain from repair of the lacerations

Chipont 2001Not a randomized controlled trial. There are no controls and all patients received topical LAT.

Liebelt 1997Not a randomized controlled trial. Instead this is a review article.

Little 2004Outcomes not relevant to this review.

Peirluisi 1989Not a randomized controlled trial, this is a retrospective study. Also the outcomes were not relevant to this review.

Priestley 2003Outcomes not relevant to this review.

Singer 2000The topical anaesthetic was only a pre-treatment prior to infiltration with local anaesthetic. Also, some of the wound closure was performed with adhesives.

Singer 2001The topical anaesthetic was only a pre-treatment prior to infiltration with local anaesthetic. Also, some of the wound closure was performed with adhesives.

Smith 1990Some patients (12) were sedated with chloral hydrate.

Smith 1998bThe study evaluated patients with lacerations located on mucous membranes.

Smith 1998cThe study evaluated patients with lacerations located on mucous membranes.

Spivey 1987Outcomes were not relevant to this review.

Stewart 1998The topical agent was not the primary anaesthetic for repair of the dermal injury. The topical agent was only a pre-treatment prior to lidocaine infiltration.

White 2004Not a randomized controlled trial. There are no controls and all patients received LAT gel.

Yamamoto 1997Outcomes were not relevant to this review.

 
Comparison 1. Topical prilocaine-phenylephrine (PP) versus topical tetracaine-epinephrine-cocaine (TAC)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Patient self-reported VAS (0-100 mm) pain scores2240Mean Difference (IV, Random, 95% CI)5.59 [-2.16, 13.35]

 
Summary of findings for the main comparison. topical local anaesthetics compared to infiltrated local anaesthetics or other topical agents for repair of dermal lacerations

topical local anaesthetics compared to infiltrated local anaesthetics or other topical agents for repair of dermal lacerations

Patient or population: patients with repair of dermal lacerations

Settings:

Intervention: topical local anaesthetics

Comparison: infiltrated local anaesthetics or other topical agents

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

infiltrated local anaesthetics or other topical agentstopical local anaesthetics

Cocaine-containing topical anaesthetics versus infiltrated local anaestheticsSee commentSee commentNot estimable1006
(6 studies)
⊕⊕⊝⊝
low1
Unable to mathematically combine results because of heterogeneity of outcome measures

Comparisons between different cocaine-containing topical anaestheticsSee commentSee commentNot estimable530
(4 studies)
⊕⊕⊝⊝
low2
Unable to mathematically combine results because each topical anaesthetic comparison limited to a single study

Cocaine-free topical anaesthetics compared to infiltrated local anaestheticsSee commentSee commentNot estimable393
(4 studies)
⊕⊕⊝⊝
low3
Unable to mathematically combine results because of heterogeneity of outcome measures

Cocaine-free topical anaesthetics compared to cocaine-containing topical anaesthetics See commentSee commentNot estimable1231
(11 studies)
⊕⊕⊝⊝
low4
Two of the eleven trials studied a common topical anaesthetic and could be mathematically combined

Comparisons between different cocaine-free topical anaestheticsSee commentSee commentNot estimable656
(5 studies)
⊕⊕⊕⊝
moderate5
The trials could not be mathematically combined because each study compared a different cocaine-free topical anaesthetic

Anaesthetic related adverse effectsStudy populationRR 0
(0 to 0)
1686
(11 studies)

1 per 10000 per 1000
(0 to 0)

Medium risk population


*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Each of the trials had high risk of bias in multiple domains or unclear risk of bias in three domains
2 Two of the four trials had at least one domain that was high risk of bias
3 Two of the trials had unclear risk of bias in multiple domains and the other two studies had high risk of bias in two domains
4 Six of the studies had high risk of bias for at least one domain and the other five studies had unclear risk of bias for one or more domains
5 Each of the five trials had unclear risk of bias in one or more domains. However, none of the trials contained any domains that were clearly high risk