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Abstract
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.
Acknowledgments
We thank Group of People with Highest Risk of Drug Exposure of International Network for the Rational Use of Drugs and program for Yangtze River Scholars and Innovative Research Team (No. IRT0935).
Author contributions
Zhe Chen conducted data analysis and wrote the manuscript. Mao Lin and Zongyao Huang retrieved and screened the literature, as well as extracted data. Linan Zeng, Liang Huang and Dan Yu established inclusion and exclusion criteria, as well as outcome indicators. Lingli Zhang designed the study and resolved the problems in research process. All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agreed to be accountable for all aspects of the work.
Disclosure
The authors report no conflicts of interest in this work.