Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel.
Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Emerg Med J. 2014 Aug;31(8):649-53. doi: 10.1136/emermed-2012-202189. Epub 2013 May 18.
To compare the efficacy of oral midazolam alone with a combination of oral midazolam and ketamine in children requiring laceration repair.
A randomised, double-blind, placebo-controlled study.
Paediatric emergency department.
Children 1-10 years of age with lacerations requiring sedation.
Using a computer-generated sequence, children were randomly assigned in blocks of four to one of two groups: oral midazolam (0.5 mg/kg) plus oral placebo and oral midazolam (0.5 mg/kg) plus oral ketamine (5 mg/kg). The allocation sequence was kept by the pharmacy staff, and the investigators were blinded to randomisation until statistical analysis of the study was completed.
Visual Analogue Scale (VAS) assessment by a parent and Sedation Score assessment by an investigator.
60 children were recruited; 29 were assigned for treatment with midazolam and 31 for the combination of midazolam and ketamine. There were no differences in basic demographics and wound characteristics between the groups. VAS assessment by a parent was 4.5±3.3 mm in the midazolam+ketamine group versus 4.4±2.7 mm in the midazolam alone group (mean difference 0.1, CI -1.9 to 1.71). Sedation Score during procedure was lower in the midazolam+ketamine group (mean difference 1.14, 95% CI 0.67 to 1.6). Intravenous sedation was required in two (6%) of the children in the midazolam+ketamine group, and in eight (27%) in the midazolam alone group. p=0.039. No clinically significant adverse effects were documented in either group.
No difference was found in pain assessment during local anaesthetic injection between the group treated with midazolam and ketamine, and the group treated with midazolam alone. The combination of oral midazolam and ketamine led to deeper sedation than midazolam alone, with less children requiring intravenous sedation.
The trial was registered in www.clinicaltrials.gov as NCT01470157.
比较单独使用口服咪达唑仑与咪达唑仑联合氯胺酮在需要行伤口修复术的儿童中的疗效。
随机、双盲、安慰剂对照研究。
儿科急诊室。
年龄在 1-10 岁之间、需要镇静的有伤口的儿童。
采用计算机生成的序列，将儿童按 4 个一组的方式随机分为两组：口服咪达唑仑（0.5mg/kg）加口服安慰剂和口服咪达唑仑（0.5mg/kg）加口服氯胺酮（5mg/kg）。药房工作人员负责保存分组序列，直到完成研究的统计分析，研究者才对分组情况设盲。
家长的视觉模拟评分（VAS）和研究者的镇静评分。
共纳入 60 例患儿；29 例接受咪达唑仑治疗，31 例接受咪达唑仑联合氯胺酮治疗。两组患儿的基本人口统计学和伤口特征无差异。家长的 VAS 评估结果为咪达唑仑联合氯胺酮组 4.5±3.3mm，咪达唑仑组 4.4±2.7mm（平均差值 0.1，CI-1.9 至 1.71）。术中镇静评分在咪达唑仑联合氯胺酮组较低（平均差值 1.14，95%CI 0.67 至 1.6）。咪达唑仑联合氯胺酮组有 2 例（6%）儿童需要静脉镇静，咪达唑仑组有 8 例（27%）需要静脉镇静。p=0.039。两组均无临床显著不良反应。
在局部麻醉注射过程中，接受咪达唑仑联合氯胺酮治疗与接受单独咪达唑仑治疗的患儿的疼痛评估无差异。咪达唑仑联合氯胺酮比单独使用咪达唑仑镇静效果更深，需要静脉镇静的儿童更少。
该试验在 www.clinicaltrials.gov 上注册，编号为 NCT01470157。
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