Efficacy and safety of rectal chloral hydrate for pediatric procedural sedation: A systematic review and meta-analysis

被引:0
作者
Chen, Zhe [1 ,2 ,3 ,4 ,5 ]
Qin, Fang [1 ,2 ,3 ,4 ,5 ]
Zeng, Linan [1 ,2 ,3 ,4 ]
Zhang, Lingli [1 ,2 ,3 ,4 ,6 ]
机构
[1] Sichuan Univ, West China Univ Hosp 2, Dept Pharm, Chengdu 610041, Peoples R China
[2] Sichuan Univ, West China Univ Hosp 2, Evidence Based Pharm Ctr, Chengdu, Peoples R China
[3] NMPA Key Lab Tech Res Drug Prod Vitro & Vivo Corre, Chengdu, Peoples R China
[4] Sichuan Univ, Key Lab Birth Defects & Related Dis Women & Childr, Minist Educ, Chengdu, Peoples R China
[5] Sichuan Univ, West China Sch Pharm, Chengdu, Peoples R China
[6] Sichuan Univ, West China Hosp, Chinese Evidence Based Med Ctr, Chengdu, Peoples R China
关键词
children; chloral hydrate; efficacy; meta-analysis; safety; sedation;
D O I
10.1097/MD.0000000000039403
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: To evaluate the efficacy and safety of rectal chloral hydrate (CH) in pediatric procedural sedation. Methods: Seven electronic databases and 3 clinical trials registry platforms were searched, and the deadline was August 2022. Randomized controlled trials evaluating the efficacy and safety of rectal CH in pediatric procedural sedation were included by 2 reviewers. The extracted outcomes included the success rate of sedation, sedation latency, sedation duration, and adverse events. The Cochrane risk of bias tool was used to assess the risk of bias. The outcomes were analyzed using Review Manager 5.3 software. Results: Forty-four randomized controlled trials with 8007 children were included in the meta-analysis. The success rate of sedation in the rectal CH group was significantly higher than that in the placebo group (risk ratio [RR], 2.60 [95% confidence interval [CI], 1.74-3.89]; P < .01; RR, 1.24 [95% CI, 1.01-1.54]; P = .04), oral CH group (RR, 1.12 [95% CI, 1.09-1.14]; I-2 = 36%; P < .001; number needed to treat [NNT] = 10), diazepam group (RR, 1.21 [95% CI, 1.10-1.33]; I-2 = 0%; P < .001; NNT = 6), phenobarbital group (RR, 1.24 [95% CI, 1.13-1.35]; I-2 = 12%; P < .001; NNT = 6), and ketamine group (RR, 1.39 [95% CI, 1.20-1.60]; I-2 = 20%; P < .001; NNT = 5). There was no significant difference in the success rate of sedation between the rectal CH group and the midazolam group (RR, 0.98 [95% CI, 0.86-1.11]; I-2 = 51%; P > .05). The sedation latency was significantly shorter in rectal CH group than that in the oral CH group (mean difference [MD], -6.36 [95% CI, -7.04 to -5.68]; I-2 = 49%; P < .001) and the phenobarbital group (MD, -7.64 [95% CI, -9.12 to -6.16]; P < .00001). The sedation duration in the rectal CH group was significantly longer than in the oral CH group (MD, 6.43 [95% CI, 4.39-8.47]; I-2 = 0%; P < .001). The overall incidence of adverse events was significantly lower with rectal CH than with oral CH (RR, 0.21 [95% CI, 0.16-0.29]; I-2 = 45%; P < .001) and ketamine (RR, 0.26 [95% CI, 0.12-0.60]; I-2 = 0%; P = .001). There was no significant difference in the overall incidence of adverse events with rectal CH compared with intramuscular midazolam (RR, 0.55 [95% CI, 0.23-1.28]; P = .17) and intranasal midazolam (RR, 3.00 [95% CI, 0.66-13.69]; P = .16). Conclusion: The available evidence suggests that rectal CH cloud be an effective and safe sedative agent for pediatric procedural sedation.
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页数:13
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