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Dexmedetomidine for procedural sedation in children

  1. Sampangiramaiah Shailaja1,*,
  2. Amita Ray2,
  3. Sujoy Ray3,
  4. Richard Kirubakaran4

Editorial Group: Cochrane Anaesthesia Group

Published Online: 19 DEC 2013

DOI: 10.1002/14651858.CD010886


How to Cite

Shailaja S, Ray A, Ray S, Kirubakaran R. Dexmedetomidine for procedural sedation in children (Protocol). Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD010886. DOI: 10.1002/14651858.CD010886.

Author Information

  1. 1

    Father Muller Medical College, Department of Anaesthesia, Mangalore, India

  2. 2

    Srinivas Medical College, Department of Obstetrics and Gynaecology, Mukka, Surathkal, Mangalore, India

  3. 3

    Kasturba Medical College, Manipal University, Manipal, Karnataka, India

  4. 4

    Christian Medical College, South Asian Cochrane Network & Centre, Prof. BV Moses & ICMR Advanced Centre for Research & Training in Evidence Informed Health Care, Vellore, Tamil Nadu, India

*Sampangiramaiah Shailaja, Department of Anaesthesia, Father Muller Medical College, Kankanady, Mangalore, 575002, India. drshaila@rediffmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 19 DEC 2013

SEARCH

 

Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Description of the condition

Current advances in diagnostic and invasive imaging technologies have increased the demand for paediatric procedural sedation outside the operating room. The incidence of minor surgical procedures done outside traditional operating rooms has also increased (Krauss 2006).

Children experience anxiety due to separation from parents and fear of injections or physicians. Anxiety can result in postoperative behavioural changes in children (Kain 1999). Hence sedation and anxiolysis play a key role in paediatric anaesthesia. Various interventions have been used to allay anxiety in children such as parental presence during induction, a preoperative preparation programme and preoperative sedative medication (Kain 1998). The most commonly practiced programme is preoperative sedative medication.

The ideal requirements for paediatric sedation include anxiolysis, amnesia, immobility and analgesia with preserved co-operation and haemodynamic stability, without causing any respiratory depression. To provide these requirements we need to use sedatives, analgesics or dissociative drugs. Various drugs have been used via different routes to provide a quiet, co-operative child. Most commonly used drugs include chloral hydrate, ketamine, midazolam and propofol. These drugs are associated with side effects such as respiratory depression, apnoea or bradycardia (Green 2003; Klein 2011; Krauss 2006; Olson 2001). Clonidine is an alpha-2 adrenergic agonist which has been tried as an oral premedicant in paediatric patients (Trevor 2012). The role of clonidine premedication for postoperative analgesia is also being investigated (Lambert 2012). The disadvantage of clonidine is its long duration of action. Dexmedetomidine is a congener of clonidine with a shorter duration of action that has been tried for procedural sedation in children (Aksu 2011; Deutsch 2007). Dexmedetomidine is also used intraoperatively as an adjunct to the inducing agent, to maintain haemodynamics, as a substitute for intraoperative and postoperative opioids, for the management of awake fibreoptic intubation and to reduce emergence agitation (He 2012; Mukhtar 2006; Patel 2010). Advantages of dexmedetomidine over other sedatives are its short duration of action and that it does not cause respiratory depression. Disadvantages are that it can cause transient hypertension followed by hypotension and bradycardia while it is not amnestic. There are case reports of dexmedetomidine triggered convulsions in paediatric patients (Tetsuo 2012; Tosun 2006).

 

Description of the intervention

Dexmedetomidine is a dextrorotatory enantiomer of medetomidine with selective affinity for the alpha-2 adrenergic receptor. It is eight times more potent than clonidine (Virtanen 1988). It was approved by the Food and Drug Administration (FDA) in 1999 for sedation during mechanical ventilation in intensive care units (ICU), for 24 hours duration; subsequently it was approved, in 2009, for monitored anaesthesia care. Following an intravenous loading dose it has a rapid phase redistribution of seven minutes, with a terminal half life of approximately two hours. It is 94% plasma protein bound and is metabolized by glucuronidation and excreted by the kidneys (Petroz 2006; Vilo 2008). Transient hypertension occurs during bolus administration due to a peripheral vasoconstrictor effect; this is followed by hypotension and bradycardia, the two main adverse effects of dexmedetomidine. Heart rate decreases by 30% in children following a loading dose (Mason 2008). Atipamezole is a specific and selective alpha-2 adrenergic antagonist which has been tried to reverse the pharmacological effects of dexmedetomidine (Karhuvaara 1991)

 

How the intervention might work

Dexmedetomidine possesses sedative, analgesic, opioid-sparing and anxiolytic properties. It exhibits its physiological effects due to stimulation of post-synaptic alpha-2 adrenergic receptors causing decreased neuronal activity and resulting in sedation and anxiolysis (Mason 2011). In the central nervous system it inhibits sympathetic activity and stimulates parasympathetic outflow in the brainstem thus causing a decrease in the heart rate and arterial blood pressure (Nelson 2003). It exhibits a direct effect on the locus ceruleus resulting in endogenous sleep with a varying depth of sedation. The analgesic effects of dexmedetomidine are due to activation of alpha-2B adrenoceptors at the level of the dorsal horn of the spinal cord and inhibiting the release of substance P, which is a neurokinin responsible for pain perception (Tobias 2007). It has an advantage over other sedatives in that it mimics natural sleep without the risk of apnoea or respiratory depression. It also causes decreased emergence agitation (crying, thrashing and disorientation experienced by children during emergence from anaesthesia), which is advantageous in children (Patel 2010). Dexmedetomidine has been used as an intravenous bolus (Lam 2013) and is also administered via the intramuscular (Mason 2012), buccal (Cimen 2012) and nasal routes (Yuen 2012) and is found to be effective. It has been used to treat iatrogenic withdrawal and to facilitate weaning of opioids and benzodiazepines in paediatric patients with cardiac disease (Baddigam 2005). Dexmedetomidine combined with ketamine preserves the haemodynamics and provides effective sedation (Koruk 2010). A meta-analysis on the use of dexmedetomidine for tonsillectomy and adenoidectomy found that dexmedetomidine was as effective as opioids in preventing postoperative pain and emergence agitation in children (He 2013). Another meta-analysis on the efficacy of intraoperative dexmedetomidine for acute postoperative pain in children concluded that there was low risk of postoperative pain following intraoperative dexmedetomidine (Schnabel 2013). There is no meta-analysis regarding the efficacy of dexmedetomidine for procedural sedation in children, hence this topic warrants a systematic review.

 

Why it is important to do this review

The presence of parents at induction of anaesthesia has not been shown to reduce anxiety or distress in children (Yip 2009). Hence pharmacological measures are essential to allay anxiety in children.

Paediatric sedation is no longer managed by anaesthesiologists alone. Medications once only used by anaesthesiologists are now utilized by non-anaesthesiologists to provide sedation to children (Havidich 2012). The efficacy and safety of dexmedetomidine in paediatric patients aged less than 18 years has not been established. Although not an FDA approved drug, more than 1000 paediatric patients have received dexmedetomidine for a variety of clinical applications inside and outside operating rooms (Easley 2008). Dexmedetomidine is expected to lose patent protection in the United States in 2013 and the acquisition cost of this drug is likely to decrease (Wunsch 2012). It will be available at affordable prices in developing countries following which there will be greater usage.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

The primary objective of this review is to evaluate and compare the efficacy and safety of dexmedetomidine as a sedative with other pharmacological methods for procedural sedation in children.

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Criteria for considering studies for this review

 

Types of studies

We will consider published and unpublished randomized and quasi-randomized controlled trials (allocation done on the basis of a pseudo-random sequence).

 

Types of participants

We will include children aged one month to 18 years who are undergoing any diagnostic, therapeutic or invasive procedure requiring sedation, analgesia or anaesthesia outside the operating room.

 

Types of interventions

Dexmedetomidine versus any sedative or opioid

We will not include studies where dexmedetomidine has been used as an adjunct to another anaesthetic agent.

 

Types of outcome measures

 

Primary outcomes

  1. Adequate sedation (Appendix 1) (as described by the study group)
  2. Haemodynamic response: a) heart rate response to dexmedetomidine (magnitude of heart rate change from baseline following administration of drug); b) blood pressure response to dexmedetomidine (magnitude of blood pressure change from baseline following administration of drug)
  3. Adverse events: a) bradycardia requiring intervention; b) hypotension requiring intervention; c) respiratory depression requiring intervention

 

Secondary outcomes

  1. Need for additional sedation or analgesia, or both (Appendix 2)
  2. Duration of stay in post-sedation care unit (in hours) or delay in discharge
  3. Incidence of emergence agitation (Appendix 3)
  4. Incidence of convulsions

 

Search methods for identification of studies

 

Electronic searches

We will conduct electronic searches of the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, most recent issue), MEDLINE (1966 to date) through Ovid, EMBASE (1988 to date) and Web of Science (1945 to date).

We will use the sensitivity maximizing search strategies described in section 6.4 of the Cochrane Handbook to search for randomized controlled trials (RCTs) in MEDLINE and EMBASE. We will not impose any language restriction in the search strategy.

We will use free text and explode associated MeSH terms as found in Appendix 4

 

Searching other resources

For ongoing trails, we will search the World Health Organization (WHO) International Clinical Trials Registry Platform. This includes clinicaltrials.gov, the meta.Register of Controlled Trials, and other national trial registries.

We will search the reference lists of all articles retrieved by the searches. We will also contact the individual researchers working in this field, organizations and pharmaceutical companies in order to identify unpublished and ongoing studies. We will present this information in a table along with the dates when this was done.

 

Data collection and analysis

 

Selection of studies

Two authors (SS and AR) will independently screen all citations and abstracts identified by the search strategy and include all eligible studies. We will assess the reports of all studies for inclusion in the review. If eligibility is unclear, we will seek more data or information from the study authors. The authors will resolve any differences regarding the eligibility of studies through discussion or consultation with a third author (SR). If a study is not eligible for inclusion, we will exclude it and document the reasons for exclusion.

We will exclude studies concerning sedation for dental procedures as there is a Cochrane review in process (Pauline 2001).

 

Data extraction and management

Two review authors (SS and AR) will independently extract the data from all the included studies using pre-tested data extraction forms (Appendix 5).

 
Study characteristics

  1. Baseline characteristics (randomized controlled trial (RCT), single or multicentre, etc)
  2. Method of sequence generation
  3. Method of allocation concealment
  4. Blinding (of participants, personnel and outcome assessors)
  5. Number of participants randomized, as well as those excluded or lost to follow-up
  6. Whether an intention-to-treat analysis was done
  7. Whether a power calculation was done
  8. Duration, timing and location of the study
  9. Source of funding

 
Participant characteristics

  1. Age
  2. Type of diagnostic or therapeutic procedure
  3. Inclusion criteria
  4. Exclusion criteria

 
Interventions

Details of the interventions, including the dose, route and duration, and other medical interventions

 
Outcomes

We will extract data for the outcomes as listed in the Types of outcome measures section.

We will compare interventions individually and versus other interventions.

 

Assessment of risk of bias in included studies

We (SS and AR) will independently extract the data on the following domains (Cochrane Handbook):

  1. random sequence generation (selection bias);
  2. allocation concealment (selection bias);
  3. blinding of participants and personnel (performance bias);
  4. blinding of outcome assessment (detection bias);
  5. incomplete outcome data (attrition bias);
  6. selective reporting (reporting bias);
  7. other bias.

We will assess the risk of bias in each included studies using the Cochrane 'Risk of bias' tool (Cochrane Handbook). We will resolve any disagreements by discussion with the third review author (SR). We will judge each domain in the risk of bias tool as 'Low risk' of bias, 'High risk' of bias, or 'Unclear risk' of bias because of either lack of information or uncertainty over the potential for bias.

 

Measures of treatment effect

For dichotomous outcomes, primary outcomes 1, 3 (adequate sedation, adverse events); secondary outcomes 1, 3, 4 (need for additional sedation or analgesia, incidence of emergence agitation, incidence of convulsions), we will use the risk ratio (RR) with the 95% confidence interval (CI). For continuous outcomes, primary outcome 2 (haemodynamic response); secondary outcome 2 (duration of stay in post-anaesthesia care unit (in hours) or delay in discharge), we will use the mean difference (MD) with the 95% CI. If continuous data have been summarized using geometric means, we shall combine them on the log scale using the generic inverse variance method and report them on the linear scale.

For some dichotomous outcomes (for example the proportion of patients having adverse events), a higher proportion represents a negative consequence of that treatment; and for other outcomes a higher proportion is considered a benefit of treatment. We will make this distinction between the categorizing of outcomes clear when we construct the summary graphs for the meta-analysis. Thus, for some of the dichotomous outcomes a treatment benefit will be displayed as risk ratio (RR) with 95% CI to the left of the centre line, while for others a treatment benefit will be displayed to the right of the centre line. For clarification, we will label the forest plots for each outcome.

If time to event outcomes are reported, we will extract the estimates of the log hazard ratio and its standard error (SE). If standard errors are not available, we will use alternative statistics that are reported in the studies to compute the SE by following the methods described in the Cochrane Handbook.

 

Unit of analysis issues

We anticipate that there will not be any cluster randomized studies.

If outcomes are reported both at baseline and at follow-up, or at trial endpoints, we will extract the mean change from baseline and the standard deviation of this mean for each group, as well as for the endpoint data. If count data are reported in trials, we will extract the total number of events in each group and the total person-time risk in each group. If count data are presented as continuous outcomes or as time to event outcomes, we will extract the same information for the respective outcomes.

When studies have reported the outcome using a per protocol analysis, we intend to perform the analysis based on intention to treat (ITT) by assuming the best case scenario.

 

Dealing with missing data

We will attempt to obtain all missing data from the study investigators. Where possible, we will extract data to allow an ITT analysis in which all randomized participants are analysed in the groups to which they were originally assigned. If there is a discrepancy between the number analysed and the number randomized, we will calculate the percentage lost to follow-up in each group and report this loss. For dichotomous outcomes, if dropouts exceed 10% for any study we will assign the worst outcome to those lost from that group and assess the impact in a sensitivity analysis by comparing the result with the result from the participants who completed the study. For continuous data, if standard deviations (SDs) are missing we will calculate them from other available data, such as SEs, or impute them using the suggested methods (Cochrane Handbook). We will not make assumptions about losses to follow-up for continuous data and will analyse the results for those who completed the study.

 

Assessment of heterogeneity

We will visually inspect the forest plot for overlapping confidence intervals along with applying the Chi2 test, with a significance level of 10%, to detect any heterogeneity. We will also use the I2 statistic, which quantifies the percentage of total variation across studies due to true variation rather than sampling error. We will grade the degree of heterogeneity as: 0% to 30%, might be important; 31% to 50%, moderate heterogeneity; 51% to 75%, substantial heterogeneity; 76% to 100%, considerable heterogeneity.

When substantial heterogeneity is found, we will explore the reason by Subgroup analysis and investigation of heterogeneity. When considerable heterogeneity is present we will not perform a meta-analysis.

 

Assessment of reporting biases

Apart from addressing the risk of reporting bias, we will assess the likelihood of publication bias using funnel plots (provided there are at least 10 studies). We will combine multiple reports of a single study under a single study identifier. We will check for discrepancies between the outcomes in published protocols against the actual reported outcomes at the end of the study (outcome reporting bias).

 

Data synthesis

The included studies may present the data for evaluation in different ways, as dichotomous outcome data or ordinal scales (for example sedation scales, measured as the Ramsay Scale, Richmond Agitation Sedation Scale; analgesia scales, visual analogue scale (VAS), a numeric scale or behaviour scale; and for emergence agitation, scales such as agitation score etc). Therefore, in the case of dichotomous data we will use risk ratio and, where possible, we plan to use the standardized mean difference (SMD) for continuous outcomes. If this is not possible, we will not pool the data but will analyse the studies separately. Similarly, we will not pool data from studies which measure outcomes using different scales.

If we undertake a meta-analysis we will use the fixed-effect model when there is no heterogeneity. Where heterogeneity is significant (I2 value of 50% or greater), we will combine the studies using the random-effects model. If a very high level of heterogeneity exists (that is the I2 value is equal to or greater than 75%) and cannot be explained, we will not combine the studies in a meta-analysis but will present the results in individual forest plots.

For dichotomous data, we will use a Mantel-Haenszel fixed-effect model to calculate the risk ratio with 95% CI.

 

Subgroup analysis and investigation of heterogeneity

We plan the following subgroup analyses as a means of investigating heterogeneous results and also to answer specific questions about the above types of interventions.

  1. Route of administration of dexmedetomidine - intravenous, intramuscular, nasal, oral.
  2. Age group of children - one month to one year, one year to three years, and three years to 18 years.
  3. Type of procedure - invasive or noninvasive, diagnostic or therapeutic.
  4. Children with neurocognitive impairment.
  5. Different dosing regimens of dexmedetomidine.

 

Sensitivity analysis

If we are able to include sufficient data, we will perform the following sensitivity analyses.

  1. Studies with a low risk of bias versus those with a high risk of bias.
  2. Studies with or without a power calculation.
  3. Studies assessing the outcome objectively versus those assessing the outcome subjectively or indirectly, as explained above.
  4. Studies with number of dropouts less than 10% versus those with more than 10% dropouts.

 

Summary of findings    [Explanations]

We will summarize the results by importing the data from RevMan 5.2 to GRADEprofiler software to create summary of findings tables.

By making judgements for each domain, using the methods described in the GRADEprofiler software, we will grade each outcome described in the Primary outcomes for the quality of the evidence.

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

This document is the result of a workshop organized by the South Asian Cochrane Network at The Christian Medical College Vellore.

We would like to thank Ronan O'Sullivan (Content editor), Marialena Trivella (Statistical editor), Anuradha Patel, Hannah Wunsch and Paul Lamber (Peer reviewers) for their help and editorial advice during the preparation of this protocol for the systematic review.

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Appendix 1. Sedation

The American Society of Anesthesiologists defines the continuum of sedation as the following.

  • Minimal sedation - normal response to verbal stimuli.
  • Moderate sedation - purposeful response to verbal/tactile stimulation (conscious sedation).
  • Deep sedation - purposeful response to repeated or painful stimulation.
  • General anesthesia - unarousable even with painful stimulus.

The different scales used to measure sedation include:

  1. Ramsay Scale - numeric scale;
  2. Richmond Agitation Sedation Scale (RASS);
  3. Minnesota Sedation Assessment Tool (MSAT);
  4. University of Michigan Sedation Scale (UMSS);
  5. Observer's Assessment of Alertness and Sedation (OAA/S).

 

Appendix 2. Analgesia

Definition: absence of the spontaneous report of pain or pain behaviours in response to stimulation that would normally be expected to be painful (Bonica's 2010).

Measurement of pain intensity, the most commonly used scales to assess pain intensity are the following.

  1. Visual analogue scale (VAS).
  2. Numerical rating scale (NRS).
  3. Verbal (Categorical) Rating Scale.

Behaviour observation method, the commonly used scales are:

  1. Faces Pain Scale - Revised (FPS-R);
  2. Face, Legs, Activity, Cry and Consolability (FLACC) Scale;
  3. Children's Hospital of Eastern Ontario Pain Scale (CHEOPS);
  4. CRIES Scale;
  5. Children and Infants' Postoperative Pain Scale (ChIPPS).

 

Appendix 3. Emergence delirium

Emergence delirium is a transient state of marked irritation and disassociation after the discontinuation of anaesthesia in some patients, which does not respond to consoling measures.

Some scales used for measuring emergence delirium are:

  1. Paediatric Anaesthesia Emergence Delirium (PAED);
  2. Watcha scale;
  3. Cravero scale;
  4. 4 Point Agitation scale.

 

Appendix 4. MEDLINE (OvidSP) search strategy

1. exp Dexmedetomidine/ or Adrenergic alpha-Agonists/ or (Precedex or Dexmedetomidin*).af. or ((adren?ergic or alpha) adj3 agonist*).mp.

2. exp Conscious Sedation/ or (procedural adj3 sedation).mp. or Perioperative Period/ or (perioperative adj3 (period or use*)).mp.
3. 1 and 2
4. (child* or pediatr*).af.
5. 3 and 4

 

Appendix 5. Data extraction form

 

CARG

 

Data collection form


Review title or ID

     



 


Study ID (surname of first author and year first full report of study was published)

     



 


Report IDs of other reports of this study (duplicate publications, follow-up studies)

     



 


Notes:       

 

 



 

 

1.     General Information

 


Date form completed (dd/mm/yyyy)     

Name/ID of person extracting data     

 

Report title

(title of paper/ abstract/ report that data are extracted from)
     

 

Report ID

(ID for this paper/ abstract/ report)
     

 

Reference details   

 

Report author contact details    

 

Publication type      

 

Study funding sources

(including role of funders)
     

 

Possible conflicts of interest

(for study authors)
     

 

Notes:       



 

 

2.     Study Eligibility

 


Study CharacteristicsEligibility criteriaYesNoUnclearLocation in text

(pg & ¶/fig/table)






Type of studyRandomized Controlled Trial     





Controlled Clinical Trial

(quasi-randomized trial)
     






Participants

(children age between one month to 18 years)
     

 

 
     






Types of intervention - Dexmedetomidine    

 

 
    






Types of outcome measures –

Sedation, heart rate, blood pressure changes, bradycardia, respiratory depression, hypotension, analgesia, delay in discharge, duration of stay in post operative ward, emergence agitation/delirium, convulsions
     

 

 
     






INCLUDE EXCLUDE 


Reason for exclusion     


Notes:     



 

DO NOT PROCEED IF STUDY EXCLUDED FROM REVIEW

 

3.     Population and setting

 


 Description

 
Location in text

(pg & ¶/fig/table)



Population description

(Age)
          



Setting

(Procedural sedation)
          



Inclusion criteria          



Exclusion criteria          



Method of recruitment of participants          



Informed consent obtained           

Yes     No    Unclear
          

Notes:        



 

 

4.     Methods

 


 Descriptions as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Aim of study           



Design (RCT/Quasi RCT)          



Unit of allocation

(by individuals, cluster/ groups or body parts)
          



Ethical approval needed/ obtained for study          

Yes     No    Unclear
          

Notes:        



 

 

5.     Risk of Bias assessment

 


DomainRisk of bias

 
Support for judgement

 
Location in text

(pg & ¶/fig/table)

Low riskHigh riskUnclear

Random sequence generation

(selection bias)
          

Allocation concealment

(selection bias)
          

Blinding of participants and personnel

(performance bias)
Outcome group: All/     

     
     

(if required)Outcome group:      

     
     

Blinding of outcome assessment

(detection bias)
Outcome group: All/     

     
     

(if required)Outcome group:      

     
     

Incomplete outcome data

(attrition bias) 
          

Selective outcome reporting?

(reporting bias)
          

Other bias

 
          

Notes:        



 

 

6.     Participants

 

 


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)

Total no. randomized

(or total pop. at start of study for NRCTs)
          

Clusters

(if applicable, no., type, no. people per cluster)
          

Baseline imbalances          

Withdrawals and exclusions

(if not provided below by outcome)
          

Age          

Sex          

Race/Ethnicity          

Other treatment received (additional to study intervention)          

Subgroups measured           

Subgroups reported           

Notes:         



 

 

7.     Intervention groups

 

 

Intervention Group 1


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)

Group name           

No. randomized to group           

Theoretical basis          

Description (dose)          

Duration of treatment period          

Timing ( frequency)          

Delivery (route)          

Providers

(anaesthesiologist/paediatrician/nurse)
          

Notes:        



 

 

8.     Outcomes

 

Primary Outcome 1


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Outcome name – Adequate sedation          



Time points measured          



Time points reported          



Outcome definition (see appendix 1)          



Person measuring/reporting          



Unit of measurement            



Scales: upper and lower limits (see appendix 1)          



Is outcome/tool validated?          

Yes     No    Unclear
          

Imputation of missing data
(e.g. assumptions made for ITT analysis)
          



Assumed risk estimate

(e.g. baseline or population risk noted  in Background)
          



Power          



Notes:        



 

Primary Outcome 2


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Outcome name – Heart rate and blood pressure response to dexmedetomidine           



Time points measured          



Time points reported          



Outcome definition (Change in haemodynamics from baseline)          



Person measuring/reporting          



Unit of measurement (beats/minutes;millimetre of mercury)           



Is outcome/tool validated?          

Yes     No    Unclear
          

Imputation of missing data
(e.g. assumptions made for ITT analysis)
          



Assumed risk estimate

(e.g. baseline or population risk noted  in Background)
          



Power          



Notes:        



 

Primary Outcome 3


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Outcome name – side effects (bradycardia, hypotension, respiratory depression)           



Time points measured          



Time points reported          



Outcome definition           



Person measuring/reporting          



Unit of measurement           



Is outcome/tool validated?          

Yes     No    Unclear
          

Imputation of missing data
(e.g. assumptions made for ITT analysis)
          



Assumed risk estimate

(e.g. baseline or population risk noted  in Background)
          



Power          



Notes:    



Secondary Outcome 1


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Outcome name – Need for additional sedation and/or analgesia            



Time points measured          



Time points reported          



Outcome definition           



Person measuring/reporting          



Unit of measurement            



Scales: upper and lower limits           



Is outcome/tool validated?          

Yes     No    Unclear
          

Imputation of missing data
(e.g. assumptions made for ITT analysis)
          



Assumed risk estimate

(e.g. baseline or population risk noted  in Background)
          



Power          



Notes:    



Secondary outcome 2


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Outcome name – Duration of stay in PACU or delay in discharge           



Time points measured          



Time points reported          



Outcome definition (patient requiring observation in high care unit)          



Person measuring/reporting          



Unit of measurement

(in hours) 
          



Is outcome/tool validated?          

Yes     No    Unclear
          

Imputation of missing data
(e.g. assumptions made for ITT analysis)
          



Assumed risk estimate

(e.g. baseline or population risk noted  in Background)
          



Power          



Notes:         



 

Secondary outcome 3


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Outcome name – Incidence of emergence agitation           



Time points measured          



Time points reported          



Outcome definition (see appendix 3)          



Person measuring/reporting          



Unit of measurement            



Is outcome/tool validated?          

Yes     No    Unclear
          

Imputation of missing data
(e.g. assumptions made for ITT analysis)
          



Assumed risk estimate

(e.g. baseline or population risk noted  in Background)
          



Power          



Notes:        



 Secondary outcome 4


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Outcome name – Incidence of convulsions           



Time points measured          



Time points reported          



Outcome definition           



Person measuring/reporting          



Unit of measurement            



Scales: upper and lower limits           



Is outcome/tool validated?          

Yes     No    Unclear
          

Imputation of missing data
(e.g. assumptions made for ITT analysis)
          



Assumed risk estimate

(e.g. baseline or population risk noted  in Background)
          



Power          



Notes:   



 

 

9.     Results

 

Dichotomous outcome


Adverse events – adequate sedation, bradycardia, hypotension, respiratory depression, additional analgesia, delay in discharge, emergence delirium, convulsionsDescription as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Comparison          



Outcome          



Subgroup(age groups, route of administration, type of procedure, neurocognitive impairment, dosing regimen)          



Timepoint
(after dexmedetomidine administration)
          



ResultsInterventionComparison     


No. eventsNo. participantsNo. eventsNo. participants




                    






No. missing participants and reasons               




No. participants moved from other group and reasons               




Any other results reported          



Unit of analysis (by individuals, cluster/groups or body parts)           



Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          



Reanalysis required? (specify)         

Yes     No    Unclear
          




Reanalysis possible?          

Yes     No    Unclear
          




Reanalysed results          



Notes:         



 

Continuous outcome


Heart rate and blood pressure changes to intervention, duration of stay in postoperative unit.Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Comparison          



Outcome          



Subgroup(age groups, route of administration, type of procedure)          



Timepoint
(after dexmedetomidine administration)
          



Post-intervention or change from baseline?          



ResultsInterventionComparison 



MeanSD (or other variance)No. participantsMeanSD (or other variance)No. participants     






                              








No. missing participants and reasons               




No. participants moved from other group and reasons               




Any other results reported           



Unit of analysis

(individuals, cluster/ groups or body parts)
          



Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          



Reanalysis required? (specify)          

Yes     No    Unclear
          




Reanalysis possible?         

Yes     No    Unclear
          




Reanalysed results          



Notes:         



 

 

 

 

 

 

 

10. Other information

 


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)

Key conclusions of study authors

 
          

References to other relevant studies

 
          

Correspondence required for further study information (from whom, what and when)     


Notes:        

 

 



 

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

Sampangiramaiah Shailaja (SS), Amita Ray (AR), Sujoy Ray (SR), Richard Kirubakaran (RK)

Conceiving the review: SS, AR

Co-ordinating the review: SS, AR, SR

Undertaking manual searches: SS, AR

Screening search results: SS, AR

Organizing retrieval of papers: SS, AR

Screening retrieved papers against inclusion criteria: SS, AR

Appraising quality of papers: SS, AR, SR

Abstracting data from papers: SS, AR

Writing to authors of papers for additional information: SR, SS

Providing additional data about papers: SS, AR

Obtaining and screening data on unpublished studies: SS, SR

Data management for the review: SS, AR, RK

Entering data into Review Manager (RevMan 5.2 ): SS, AR, SR

RevMan statistical data: RK, SR

Other statistical analysis not using RevMan: RK

Interpretation of data: RK, SS

Statistical inferences: RK, AR

Writing the review: SS, AR, SR, RK

Securing funding for the review: none

Performing previous work that was the foundation of the present study: none

Guarantor for the review (one author) SS

Person responsible for reading and checking review before submission: SS, AR, SR, RK

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

Sampangiramaiah Shailaja: none known

Amita Ray: none known

Sujoy Ray: none known

Richard Kirubakaran: none known

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Internal sources

  • No source of support provided, Not specified.

 

External sources

  • No sources of support supplied

References

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Acknowledgements
  7. Appendices
  8. Contributions of authors
  9. Declarations of interest
  10. Sources of support
  11. Additional references
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