Pain relief for neonatal circumcision
Editorial Group: Cochrane Neonatal Group
Published Online: 19 JUL 2004
Assessed as up-to-date: 2 AUG 2005
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
How to Cite
Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD004217. DOI: 10.1002/14651858.CD004217.pub2.
- Publication Status: Edited (no change to conclusions)
- Published Online: 19 JUL 2004
Circumcision is a painful procedure that many newborn males undergo in the first few days after birth. Interventions are available to reduce pain at circumcision; however, many newborns are circumcised without pain management.
The objective of this review was to assess the effectiveness and safety of interventions for reducing pain at neonatal circumcision.
We searched Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2004), MEDLINE (1966 - April 2004), EMBASE (1988 - 2004 week 19), CINAHL (1982 - May week 1 2004), Dissertation Abstracts (1986 - May 2004), Proceedings of the World Congress on Pain (1993 - 1999), and reference lists of articles. Language restrictions were not imposed.
Randomised controlled trials comparing pain interventions with placebo or no treatment or comparing two active pain interventions in male term or preterm infants undergoing circumcision.
Data collection and analysis
Two independent reviewers assessed trial quality and extracted data. Ten authors were contacted for additional information. Adverse effects information was obtained from the trial reports. For meta-analysis, data on a continuous scale were reported as weighted mean difference (WMD) or, when the units were not compatible, as standardized mean difference.
Thirty-five trials involving 1,997 newborns were included. Thirty-three trials enrolled healthy, full term neonates, and two enrolled infants born preterm.
Fourteen trials involving 592 newborns compared dorsal penile nerve block (DPNB) with placebo or no treatment. Compared to placebo/no treatment, DPNB demonstrated significantly lower heart rate [WMD -35 bpm, 95% CI -41 to -30], decreased time crying [WMD -54 %, 95% CI -64 to -44], and increased oxygen saturation [WMD 3.7 %, 95% CI 2.7 to 3.7]. Six trials involving 200 newborns compared eutectic mixture of analgesics (EMLA) with placebo. EMLA demonstrated significantly lower facial action scores [WMD -46.5, 95% CI -80.4 to -12.6], decreased time crying [WMD - 15.2 %, 95% CI -21 to -9.3] and lower heart rate [WMD -15 bpm, 95% CI -19 to -10]. DPNB, compared with EMLA in three trials involving 139 newborns (133 of whom were included in the analysis), demonstrated significantly lower heart rate [WMD -17 bpm, 95% CI -23 to -11] and pain scores. When compared with sucrose in two trials involving 127 newborns, DPNB demonstrated less time crying [MD -166 s, 95% CI -211 to -121], and lower heart rate [WMD -27 bpm, 95% CI -33 to -20]. Results obtained for trials comparing oral sucrose and oral analgesics to placebo, and trials of environmental modification were either inconsistent or were not significantly different.
Adverse effects included gagging, choking, and emesis in placebo/untreated groups. Minor bleeding, swelling and hematoma were reported with DPNB. Erythema and mild skin pallor were observed with the use of EMLA. Methaemoglobin levels were evaluated in two trials of EMLA, and results were within normal limits.
DPNB was the most frequently studied intervention and was the most effective for circumcision pain. Compared to placebo, EMLA was also effective, but was not as effective as DPNB. Both interventions appear to be safe for use in newborns. None of the studied interventions completely eliminated the pain response to circumcision.
Plain language summary
Pain relief for neonatal circumcision
Circumcision is a painful procedure frequently performed on newborn baby boys without using pain relief. Available treatments include dorsal penile nerve block (DPNB), which involves injecting anesthetic at the base of the penis. Ring block is another form of penile block. Locally applied anesthetic creams include EMLA, a water-based cream including lidocaine and prilocaine. Based on 35 clinical trials involving 1,997 newborns, it can be concluded that DPNB and EMLA do not eliminate circumcision pain, but are both more effective than placebo or no treatment in diminishing it. Compared head to head, DPNB is substantially more effective than EMLA cream. Ring block and lidocaine creams other than EMLA also reduced pain but did not eliminate it. Trials of oral acetaminophen, sugar solutions, pacifiers, music, and other environmental modifications to reduce circumcision pain did not prove them effective. DPNB can cause minor bruising, bleeding, or swelling at the injection site. EMLA and other lidocaine creams can cause skin color changes or local skin irritation. There is a rare risk with lidocaine creams of causing methaemoglobinaemia (blue-baby syndrome, where the baby's blood lacks sufficient oxygen). However, two trials of EMLA for circumcision pain relief measured methaemoglobin levels and found them normal. The circumcision procedure itself, especially without pain relief, can cause short term effects such as choking, gagging, and vomiting. Long term effects of circumcision without pain relief are not well understood. Strict comparability between trials was rare. Trials used a variety of indicators to measure baby's pain. Crying time, facial expression, and sweating palms can indicate infant pain, as can increased heart rate, breathing rate, and blood pressure. Levels of chemical indicators that can be part of a pain or stress response and are present in the blood or saliva are another gauge of pain levels. Also, procedures were not generally performed in just the same way in different trials. Type of clamp used (8sing a Mogen clamp can shorten the duration of the procedure), length of wait time after injection or application of anesthetic and procedure techniques varied.
我們搜尋了Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2004)、 MEDLINE (1966 April 2004)、 EMBASE (1988 – 2004 week 19),、 CINAHL (1982 May week 1 2004)、學位論文摘要(1986 May 2004)、世界疼痛會議的會刊(1993 – 1999)，及文章的參考文獻。沒有設定語言的限制。
兩個獨立評論者評估試驗品質和擷取資料。聯繫十個作者得到額外資料。 不良效應的資料由試驗報告中獲得。 在統合分析方面，連續的資料經加權均數呈現或是當單位不相符時以標準化平均差呈現。
有35個試驗包含1997位新生兒。其中33個試驗包含健康足月之新生兒，而另外2個試驗收案個案為早產兒。有14個試驗(592位新生兒)以背側陰莖神經阻斷術與安慰組或沒有介入組作比較。使用背側陰莖神經阻斷術組比起安慰組或是沒有介入組有較低的心跳[WMD −35 bpm, 95% CI −41 to −30]、 較短的哭泣時間[WMD −54 %, 95% CI −64 to −44]、以及較高的的血氧飽和度[WMD 3.7 %, 95% CI 2.7 to 3.7]。有6個試驗(200位新生兒)比較使用ELMA麻醉法和對照組。使用ELMA麻醉法有顯著較低的臉部動作分數 WMD −46.5, 95% C 80.4 to −12.6]， 較低的哭泣時間 [WMD −15.2 %, 95% CI −20 – 9.3]，以及較低的心跳 WMD −15 bpm, 95% CI −19 to −10]。在3個試驗中(139位中有133位接受分析),背側陰莖神經阻斷組比起使用ELMA麻醉法有顯著較低的心跳[WMD −17 bpm, 95% CI −23 to −11] 和疼痛分數。在2個試驗中(127位新生兒),背側陰莖神經阻斷組比起使用蔗糖組有顯著較少的哭泣時間 [MD −166 s, 95% CI −211 to −121], 和較低的心跳 [WMD −27 bpm, 95% CI −33 to −20]。比較口服蔗糖、口服止痛藥和安慰組、及環境調整，其結果往往不一致或是沒有顯著差異。在安慰組或是未治療組，副作用包含作嘔、嗆到、噁心。背側陰莖神經阻斷組則有輕微出血、腫脹或血腫。 使用ELMA麻醉法會觀察到皮膚呈現紅斑或是輕微蒼白之情形。 在兩個使用ELMA的試驗有評估Methaemoglobin 濃度，其結果是在正常範圍之內。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
割包皮手術是個令人疼痛的過程卻常在沒有疼痛控制的情況下於男性新生兒身上執行。可使用的方法包含背側陰莖神經阻斷(在陰莖根部注射麻醉藥)。環狀阻斷是另一種陰莖阻斷方法。局部塗抹麻醉藥膏包括EMLA及含有lidocaine 和 prilocaine水性軟膏。根據35個試驗(1197位新生兒)，背側陰莖神經阻斷和ELMA麻醉法無法消除割包皮的疼痛，但是都比安慰組或是未治療組有效。比較上，神經阻斷比ELMA軟膏有效。環狀阻斷法和lidocaine軟膏也可以減輕但無法消除疼痛。使用口服acetaminophen、糖溶液、奶嘴、音樂或其他環境療法未被證實可以有效緩解割包皮之疼痛。背側陰莖神經阻斷會在注射處導致輕微瘀青、出血、或是腫脹。混合止痛劑和lidocaine軟膏會導致皮膚顏色變化和局部皮膚刺激。lidocaine軟膏有很小的危險性會導致變性血紅素血症 (bluebaby syndrome, 嬰兒血液缺乏足夠氧氣)。 然而有兩個試驗測量methaemoglobin 濃度顯示在正常範圍。割包皮本身，尤其在不止痛的情況下，會導致短期效應像是作嘔、嗆到、嘔吐。 割包皮而不止痛的長期效應並未明瞭。只有很少試驗有嚴謹的比較。試驗中應用各種不同的指標測量疼痛。哭泣的時間、臉部表情、手心出汗以及心跳、呼吸和血壓上升等可用來表示嬰兒的疼痛。血液或是口水之化學測量是另一種測量痛之指標。此外，在不同研究中使用的止痛步驟也不盡相同。例如夾鉗方式、注射後等待的時間或施行麻醉藥之方法或步驟皆不一樣。