Purpose: To determine safety and efficacy of oral chloral hydrate sedation (CHS) for outpatient pediatric ophthalmic procedures. Design: Prospective, interventional case series. Methods: Setting: King Khaled Eye Specialist Hospital. Subjects: Children aged 1 month to 5 years undergoing CHS for ocular imaging/evaluation. Procedures: Details on chloral hydrate dose administered, sedation achieved, vital signs, and adverse events were recorded. Outcome Measures: Primary outcome was percentage of patients with a sedation level ≥ 4 at 45 minutes post chloral hydrate administration. Secondary outcomes were time from sedation to discharge and adverse events, including changes in vital signs following chloral hydrate administration. Results: A total of 324 children were recruited with a mean age of 2.2 (SD: 1.3) years and mean weight of 10.9 (SD: 3.3) kg. Adequate sedation was obtained with a mean chloral hydrate first dose of 77.4 (SD: 14.7) mg/kg in 306 (94.4%) patients, with an additional 6 patients (1.9%) achieving adequate sedation with a second dose (overall adequate sedation: 96.3%). Mean reductions in heart rate, respiratory rate, and oxygen (O2) saturation from pre-sedation to 25 minutes post-sedation were 11.7 (SD: 14.3) beats per minute, 1.2 (SD: 2.4) breaths per minute, and 0.81% (SD: 1.2%), respectively (P <.001 for all). In multivariable regression, odds of remaining sedated 45 minutes after chloral hydrate administration were 2.53 times higher for American Society of Anesthesiologists (ASA) class II or III patients than for ASA class I (95% confidence interval [CI]: 1.11–5.78, P =.03), 1.03 times higher per mg increase in initial dose of chloral hydrate (95% CI: 1.01–1.06, P =.006), and 2.70 times higher per unit increase in number of planned procedures (95% CI: 1.63–4.47, P <.001). Three patients developed minor adverse events: 2 cases of O2 desaturation and 1 paradoxical reaction, none requiring significant intervention. Patients were discharged a median of 90 minutes after chloral hydrate administration. Conclusion: Chloral hydrate administered by a dedicated sedation service, as in this prospective assessment, can be used safely and effectively for outpatient pediatric ophthalmic procedures.
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