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布洛芬与对乙酰氨基酚加可待因治疗小儿急性手臂骨折疼痛的随机临床试验。

A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain.

作者信息

Drendel Amy L, Gorelick Marc H, Weisman Steven J, Lyon Roger, Brousseau David C, Kim Michael K

机构信息

Pediatric Emergency Medicine Division, Medical College of Wisconsin, Milwaukee, WI, USA.

出版信息

Ann Emerg Med. 2009 Oct;54(4):553-60. doi: 10.1016/j.annemergmed.2009.06.005. Epub 2009 Aug 19.

DOI:10.1016/j.annemergmed.2009.06.005
PMID:19692147
Abstract

STUDY OBJECTIVE

We compare the treatment of pain in children with arm fractures by ibuprofen 10 mg/kg versus acetaminophen with codeine 1 mg/kg/dose (codeine component).

METHODS

This was a randomized, double-blind, clinical trial of children during the first 3 days after discharge from the emergency department (ED). The primary outcome was failure of the oral study medication, defined as use of the rescue medication. Pain medication use, pain scores, functional outcomes, adverse effects, and satisfaction were also assessed.

RESULTS

Three hundred thirty-six children were randomized to treatment, 169 to ibuprofen and 167 to acetaminophen with codeine; 244 patients were analyzed. Both groups used a median of 4 doses (interquartile range 2, 6.5). The proportion of treatment failures for ibuprofen (20.3%) was lower than for acetaminophen with codeine (31.0%), though not statistically significant (difference=10.7%; 95% confidence interval -0.2 to 21.6). The proportion of children who had any function (play, sleep, eating, school) affected by pain when pain was analyzed by day after injury was significantly lower for the ibuprofen group. Significantly more children receiving acetaminophen with codeine reported adverse effects and did not want to use it for future fractures.

CONCLUSION

Ibuprofen was at least as effective as acetaminophen with codeine for outpatient analgesia for children with arm fractures. There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes. Children receiving ibuprofen had significantly fewer adverse effects, and both children and parents were more satisfied with ibuprofen. Ibuprofen is preferable to acetaminophen with codeine for outpatient treatment of children with uncomplicated arm fractures.

摘要

研究目的

我们比较布洛芬10毫克/千克与对乙酰氨基酚加可待因1毫克/千克/剂量(可待因成分)对儿童手臂骨折疼痛的治疗效果。

方法

这是一项针对急诊科(ED)出院后前3天儿童的随机、双盲临床试验。主要结局是口服研究药物失败,定义为使用了急救药物。还评估了止痛药物的使用、疼痛评分、功能结局、不良反应和满意度。

结果

336名儿童被随机分配接受治疗,169名接受布洛芬治疗,167名接受对乙酰氨基酚加可待因治疗;对244名患者进行了分析。两组的药物使用中位数均为4剂(四分位间距为2, 6.5)。布洛芬组的治疗失败比例(20.3%)低于对乙酰氨基酚加可待因组(31.0%),但差异无统计学意义(差值 = 10.7%;95%置信区间为 -0.2至21.6)。按受伤后天数分析疼痛时,布洛芬组中因疼痛影响任何功能(玩耍、睡眠、进食、上学)的儿童比例显著更低。服用对乙酰氨基酚加可待因的儿童报告有不良反应且表示未来骨折不想再用该药的比例显著更高。

结论

对于手臂骨折的儿童门诊镇痛,布洛芬至少与对乙酰氨基酚加可待因效果相当。镇痛失败率或疼痛评分无显著差异,但服用布洛芬的儿童功能结局更好。服用布洛芬的儿童不良反应显著更少,儿童和家长对布洛芬的满意度也更高。对于无并发症的手臂骨折儿童门诊治疗,布洛芬比 对乙酰氨基酚加可待因更可取。

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