Chloral hydrate outperforms oral midazolam in facilitating venipuncture in children: a double-blind randomized trial

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.