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Efficacy of chloral hydrate oral solution for sedation in pediatrics: a systematic review and meta-analysis
Zhe Chen1,2,3, Mao Lin1,2,3,4, Zongyao Huang1,2,3,4
1Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, People's Republic of China.
Insights
Chloral hydrate (CH) is an effective sedation agent for pediatric procedures, showing higher success rates compared to placebo and midazolam. This review confirms CH oral solution as a suitable alternative for pediatric sedation.
Area of Science:
- Pediatric Sedation
- Pharmacology
- Evidence-Based Medicine
Background:
- Chloral hydrate (CH) is a widely used sedation agent for pediatric procedures in China.
- Currently, CH is only available as a hospital preparation and not commercially marketed.
- There is a need to systematically evaluate the efficacy of CH in children for procedural sedation.
Purpose of the Study:
- To systematically evaluate the efficacy of chloral hydrate (CH) for sedation in children of all age groups before medical procedures.
- To compare the effectiveness of CH with placebo, midazolam, diazepam, dexmedetomidine, and barbiturates.
Main Methods:
- A meta-analysis of 24 randomized controlled trials (RCTs) involving 3564 children was conducted.
- Data on sedation success rate, latency, and duration were extracted and analyzed.
- The Cochrane risk of bias tool was used to assess study quality.
Main Results:
- CH significantly increased sedation success rates compared to placebo for both painless and painful procedures.
- CH demonstrated higher success rates, shorter latency, and longer duration compared to midazolam.
- No significant differences in sedation success rates were observed when comparing CH to diazepam, dexmedetomidine, or barbiturates.
Conclusions:
- Chloral hydrate (CH) oral solution is an effective and appropriate alternative for pediatric sedation.
- The findings support the use of CH for procedural sedation in children based on existing literature.
Objective:
Chloral hydrate (CH), as a sedation agent, is widely used in children for diagnostic or therapeutic procedures. However, it has not come into the market and is currently only used as hospital preparation in China. This review aims to systematically evaluate the efficacy of CH in children of all age groups for sedation before medical procedures.
Materials And Methods:
Seven electronic databases and three clinical trial registry platforms were searched and the deadline was September 2018. Randomized controlled trials (RCTs) evaluating the efficacy of CH for sedation in children were included by two reviewers. The extracted information included success rate of sedation, sedation latency and sedation duration. The Cochrane risk of bias tool was applied to assess the risk of bias. The outcomes were analyzed by Review Manager 5.3 software and expressed as relative risks (RR) or Mean Difference (MD) with 95% confidence interval (CI). Heterogeneity was assessed with I-squared (I2) statistics.
Results:
A total of 24 RCTs involving 3564 children of CH for sedation were included in the meta-analysis. Compared to placebo group, CH group had a significant increase in success rate of sedation when used for painless and painful procedure (RR=4.15, 95% CI [1.21, 14.24], P=0.02; RR=1.28, 95% CI [1.17, 1.40], P<0.01), which included 22 and 455 children for this analysis, respectively. Compared to midazolam group, CH group had a significant increase in success rate of sedation (RR=1.63, 95% CI [1.48, 1.79], I2=0%, P<0.00001), sedation latency (MD=13.29, 95% CI [11.42, 15.16], I2=0%, P<0.00001) and sedation duration (MD=17.52, 95% CI [10.3, 24.71], I2=0%, P<0.05), which included 1052, 710 and 727 children for this analysis, respectively. Compared to diazepam, there was no significant difference in success rate of sedation (RR=0.93, 95% CI [0.80, 1.08], I2=52%, P=0.32), which included 230 children for this analysis. Compared to dexmedetomidine, there was no significant difference in the success rate of sedation (RR=0.92, 95% CI [0.80, 1.06], I2=48%, P=0.27) and sedation latency (RR=-1.09, 95% CI [-2.45, 0.26], I2=26%, P=0.11), which included 512 and 371 children for this analysis, respectively. Compared to barbiturates, there was no significant difference in the success rate of sedation (RR=1.03, 95% CI [0.94, 1.13], I2=50%, P=0.58) and sedation duration (MD=-0.72, 95% CI [-1.78, 0.34], I2=38%, P=0.18), which included 749 and 210 children for this analysis, respectively.
Conclusions:
From the extrapolation of the existing literature, CH oral solution is an appropriate effective alternative for sedation in pediatrics.
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