Le May Sylvie, Ali Samina, Plint Amy C, Mâsse Benoit, Neto Gina, Auclair Marie-Christine, Drendel Amy L, Ballard Ariane, Khadra Christelle, Villeneuve Edith, Parent Stefan, McGrath Patrick J, Leclair Grégoire, Gouin Serge
Faculties of Nursing and
CHU Sainte-Justine Research Center, Montreal, Quebec, Canada.
Pediatrics. 2017 Nov;140(5). doi: 10.1542/peds.2017-0186. Epub 2017 Oct 11.
Musculoskeletal injuries (MSK-Is) are a common and painful condition among children that remains poorly treated in the emergency department (ED). We aimed to test the efficacy of a combination of an anti-inflammatory drug with an opioid for pain management of MSK-I in children presenting to the ED.
In this randomized, double-blinded, placebo-controlled trial, we enrolled children between 6 and 17 years presenting to the ED with an MSK-I and a pain score >29 mm on the visual analog scale (VAS). Participants were randomly assigned to oral morphine (0.2 mg/kg) + ibuprofen (10 mg/kg) (morphine + ibuprofen) or morphine (0.2 mg/kg) + placebo of ibuprofen or ibuprofen (10 mg/kg) + placebo of morphine. Primary outcome was children with VAS pain score <30 mm at 60 minutes postmedication administration.
A total of 501 participants were enrolled and 456 were included in primary analyses (morphine + ibuprofen = 177; morphine = 188; ibuprofen = 91). Only 29.9% (morphine + ibuprofen), 29.3% (morphine), and 33.0% (ibuprofen) of participants achieved the primary outcome ( = .81). Mean VAS pain reduction at 60 minutes were -18.7 (95% confidence interval [CI]: -21.9 to -16.6) (morphine + ibuprofen), -17.0 (95% CI: -20.0 to -13.9) (morphine), -18.6 (95% CI: -22.9 to -14.2) (ibuprofen) ( = .69). Children in the morphine + ibuprofen group ( < .001) and in the morphine group ( < .001) experienced more side effects than those in the ibuprofen group. No serious adverse event was reported.
Combination of morphine with ibuprofen did not provide adequate pain relief for children with MSK-I in the ED. None of the study medication provided an optimal pain management because most of children did not reach a mild pain score (NCT02064894).
肌肉骨骼损伤（MSK-Is）在儿童中是一种常见且疼痛的病症，在急诊科（ED）的治疗效果仍然不佳。我们旨在测试一种抗炎药物与一种阿片类药物联合使用对到急诊科就诊的患有MSK-I的儿童进行疼痛管理的疗效。
在这项随机、双盲、安慰剂对照试验中，我们纳入了6至17岁因MSK-I到急诊科就诊且视觉模拟量表（VAS）疼痛评分>29毫米的儿童。参与者被随机分配接受口服吗啡（0.2毫克/千克）+布洛芬（10毫克/千克）（吗啡+布洛芬）或吗啡（0.2毫克/千克）+布洛芬安慰剂或布洛芬（10毫克/千克）+吗啡安慰剂。主要结局是用药后60分钟时VAS疼痛评分<30毫米的儿童。
共纳入501名参与者，456名纳入主要分析（吗啡+布洛芬=177名；吗啡=188名；布洛芬=91名）。只有29.9%（吗啡+布洛芬）、29.3%（吗啡）和33.0%（布洛芬）的参与者达到主要结局（P = 0.81）。用药后60分钟时VAS疼痛评分的平均降低值分别为-18.7（95%置信区间[CI]：-21.9至-16.6）（吗啡+布洛芬）、-17.0（95%CI：-20.0至-13.9）（吗啡）、-18.6（95%CI：-22.9至-14.2）（布洛芬）（P = 0.69）。吗啡+布洛芬组（P<0.001）和吗啡组（P<0.001）的儿童比布洛芬组的儿童出现更多副作用。未报告严重不良事件。
吗啡与布洛芬联合使用对急诊科患有MSK-I的儿童未能提供足够的疼痛缓解。没有一种研究药物能提供最佳的疼痛管理，因为大多数儿童未达到轻度疼痛评分（NCT02064894）。
