A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children
A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children
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DOI：
10.1182/blood-2015-05-647107
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发表时间：
2015-10-01
期刊：
影响因子：
20.3
通讯作者：
Panepinto, Julie A.
中科院分区：
文献类型：
--
作者：
Brousseau, David C.;Scott, J. Paul;Panepinto, Julie A.
镁是一种血管扩张剂、抗炎和止痛药，可以改变镰状细胞疼痛危机的病理生理学。我们假设静脉注射镁可以缩短住院时间，减少阿片类药物的使用，并改善因镰状细胞疼痛危象住院的儿童患者的健康相关生活质量(HRQL)。危机中儿童镁(MAGIC)研究是一项随机、双盲、安慰剂对照的静脉注射镁与生理盐水安慰剂的试验，在儿科急救应用研究网络(PECARN)内的8个地点进行。4~21岁因疼痛住院的HbSS或Sβ(0)地中海贫血的儿童符合条件。儿童每8小时接受40毫克/公斤的镁或安慰剂治疗，最多6剂，外加标准治疗。使用Van Elteren检验比较，主要结果是从第一次研究药物输注时间起的住院时间(以小时为单位)。次要结果包括阿片类药物的使用和HRQL。在208名登记的儿童中，204人接受了研究药物(101镁，103安慰剂)。组间人口学特征和随机前治疗相似。镁治疗组的平均住院时间为56.0h(27.0-109.0)小时，安慰剂组为47.0h(24.0-99.0小时)(P=0.24)。镁患者接受了1.46毫克/公斤的吗啡当量，而安慰剂为1.28毫克/公斤(P=.12)。出院前和出院后1周的HRQL变化相似(均为P>；05)。静脉注射镁并没有缩短住院时间，减少阿片类药物的使用，也没有改善因镰状细胞疼痛危象而住院的儿童的生活质量。这项试验在www.Clinicaltrials.gov上注册为#NCT01197417。
Magnesium, a vasodilator, anti-inflammatory, and pain reliever, could alter the pathophysiology of sickle cell pain crises. We hypothesized that intravenous magnesium would shorten length of stay, decrease opioid use, and improve health-related quality of life (HRQL) for pediatric patients hospitalized with sickle cell pain crises. The Magnesium for Children in Crisis (MAGiC) study was a randomized, double-blind, placebo-controlled trial of intravenous magnesium vs normal saline placebo conducted at 8 sites within the Pediatric Emergency Care Applied Research Network (PECARN). Children 4 to 21 years old with hemoglobin SS or S beta(0) thalassemia requiring hospitalization for pain were eligible. Children received 40 mg/kg of magnesium or placebo every 8 hours for up to 6 doses plus standard therapy. The primary outcome was length of stay in hours from the time of first study drug infusion, compared using a Van Elteren test. Secondary outcomes included opioid use and HRQL. Of 208 children enrolled, 204 received the study drug (101 magnesium, 103 placebo). Between-group demographics and prerandomization treatment were similar. The median interquartile range (IQR) length of stay was 56.0 (27.0-109.0) hours for magnesium vs 47.0 (24.0-99.0) hours for placebo (P = .24). Magnesium patients received 1.46 mg/kg morphine equivalents vs 1.28 mg/kg for placebo (P = .12). Changes in HRQL before discharge and 1 week after discharge were similar (P > 05 for all comparisons). The addition of intravenous magnesium did not shorten length of stay, reduce opioid use, or improve quality of life in children hospitalized for sickle cell pain crisis. This trial was registered at www.clinicaltrials.gov as #NCT01197417.