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口服吗啡与布洛芬在家用于儿童骨科术后疼痛的比较:一项随机对照试验。

Oral morphine versus ibuprofen administered at home for postoperative orthopedic pain in children: a randomized controlled trial.

作者信息

Poonai Naveen, Datoo Natasha, Ali Samina, Cashin Megan, Drendel Amy L, Zhu Rongbo, Lepore Natasha, Greff Michael, Rieder Michael, Bartley Debra

机构信息

Division of Emergency Medicine (Poonai, Zhu, Lepore), London Health Sciences Centre; Department of Paediatrics (Poonai, Datoo, Greff, Rieder) and Department of Surgery (Cashin, Bartley), Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine and Dentistry, Women and Children's Health Research Institute, University of Alberta, Edmonton, Alta.; Children's Hospital of Wisconsin (Drendel), Milwaukee, Wis.

出版信息

CMAJ. 2017 Oct 10;189(40):E1252-E1258. doi: 10.1503/cmaj.170017.

Abstract

BACKGROUND

Oral morphine for postoperative pain after minor pediatric surgery, while increasingly popular, is not supported by evidence. We evaluated whether oral morphine was superior to ibuprofen for at-home management of children's postoperative pain.

METHODS

We conducted a randomized superiority trial comparing oral morphine (0.5 mg/kg) with ibuprofen (10 mg/kg) in children 5 to 17 years of age who had undergone minor outpatient orthopedic surgery (June 2013 to September 2016). Participants took up to 8 doses of the intervention drug every 6 hours as needed for pain at home. The primary outcome was pain, according to the Faces Pain Scale - Revised, for the first dose. Secondary outcomes included additional analgesic requirements, adverse effects, unplanned health care visits and pain scores for doses 2 to 8.

RESULTS

We analyzed data for 77 participants in each of the morphine and ibuprofen groups. Both interventions decreased pain scores with no difference in efficacy. The median difference in pain score before and after the first dose of medication was 1 (interquartile range 0-1) for both morphine and ibuprofen ( = 0.2). For doses 2 to 8, the median differences in pain score before and after the dose were not significantly different between groups. Significantly more participants taking morphine reported adverse effects (45/65 [69%] v. 26/67 [39%], < 0.001), most commonly drowsiness (31/65 [48%] v. 15/67 [22%] in the morphine and ibuprofen groups, respectively; = 0.003).

INTERPRETATION

Morphine was not superior to ibuprofen, and both drugs decreased pain with no apparent difference in efficacy. Morphine was associated with significantly more adverse effects, which suggests that ibuprofen is a better first-line option after minor surgery.

TRIAL REGISTRATION

ClinicalTrials.gov, no. NCT01686802.

摘要

背景

小儿小手术后口服吗啡用于术后疼痛治疗,虽日益普遍,但缺乏证据支持。我们评估了在家中处理儿童术后疼痛时,口服吗啡是否优于布洛芬。

方法

我们进行了一项随机优效性试验,比较口服吗啡(0.5毫克/千克)与布洛芬(10毫克/千克)对5至17岁接受小门诊骨科手术的儿童(2013年6月至2016年9月)的效果。参与者根据家中疼痛情况,每6小时按需服用最多8剂干预药物。主要结局为根据面部疼痛量表修订版得出的首剂疼痛情况。次要结局包括额外的镇痛需求、不良反应、非计划的医疗就诊以及第2至8剂的疼痛评分。

结果

我们分析了吗啡组和布洛芬组各77名参与者的数据。两种干预措施均降低了疼痛评分,疗效无差异。首剂用药前后疼痛评分的中位数差值,吗啡组和布洛芬组均为1(四分位间距0 - 1)(P = 0.2)。对于第2至8剂,两组用药前后疼痛评分的中位数差值无显著差异。服用吗啡的参与者报告不良反应的显著更多(45/65 [69%] 对比 26/67 [39%],P < 0.001),最常见的是嗜睡(吗啡组31/65 [48%],布洛芬组15/67 [22%];P = 0.003)。

解读

吗啡并不优于布洛芬,两种药物均能减轻疼痛,疗效无明显差异。吗啡的不良反应显著更多,这表明布洛芬是小手术后更好的一线选择。

试验注册

ClinicalTrials.gov,编号NCT01686802。

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本文引用的文献

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Parental Report of Morphine Use at Home after Pediatric Surgery.家长报告小儿手术后家中使用吗啡情况。
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