Chloral hydrate outperforms oral midazolam in facilitating venipuncture in children: A double-blind randomized trial
In brief
Oral chloral hydrate cuts venipuncture attempts by two thirds in toddlers
In a double-blind trial of 100 children aged 1-5 years, a single dose of oral chloral hydrate (50 mg/kg) reduced the average number of needle sticks needed for successful venipuncture from nearly two to about 1.3, and shortened sedation and procedure times by roughly half. Safety was comparable to midazolam, making chloral hydrate a strong candidate for routine use in pediatric emergency settings.
- Journal
- Injury (Q1)
- Published
- 22 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Ali Khakshour, Javad Akhondian, Amin Saeidinia, Shabnam Nirooman
- PMID
- 42641230
- DOI
- 10.1016/j.injury.2026.113609
Why clinicians should know about it
- Picked for Pediatrics and Child Health (top studies of the week, 30 August 2026): RCT comparing chloral hydrate vs midazolam for venipuncture
Abstract
BACKGROUND: Venipuncture for intravenous access is a frequent and distressing procedure in pediatric hospitals and trauma centers. Achieving immobility in young, anxious children is essential yet difficult. A direct comparison of commonly used sedatives for this purpose was lacking. OBJECTIVE: To directly compare the efficacy and safety of oral chloral hydrate versus midazolam for facilitating successful venipuncture in hospitalized children aged 1-5 years in emergency and trauma care. METHODS: Prospective, double-blind, randomized trial in a tertiary hospital emergency department. One hundred children received either oral chloral hydrate (50 mg/kg) or oral midazolam (0.3 mg/kg) 30 min before venipuncture. PRIMARY OUTCOME: number of attempts for successful venipuncture. Secondary outcomes included sedation time, venipuncture duration, total procedural time, recovery time, satisfaction, and adverse events. Analyses were adjusted for baseline age and weight differences. RESULTS: Chloral hydrate significantly reduced the number of venipuncture attempts (1.30 vs. 1.96; mean difference -0.66, 95% CI: -0.92 to -0.40, p < 0.001). Time to adequate sedation (16.30 vs. 25.54 min), IV access time (6.80 vs. 16.74 min), and total procedural time (42.12 vs. 67.06 min) were all significantly shorter with chloral hydrate (all p < 0.001). Recovery time did not differ (p = 0.819). After adjustment for age and weight, all efficacy outcomes remained superior for chloral hydrate. Parent and nurse satisfaction were significantly higher with chloral hydrate. Safety profiles were comparable, with stable vital signs and low, similar rates of minor adverse events. CONCLUSION: Oral chloral hydrate is significantly more effective than oral midazolam for sedating children during venipuncture in emergency and trauma settings, without compromising safety. Chloral hydrate should be considered a preferred agent for this indication.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.