Clinical and Stability Assessment of Chloral Hydrate Syrup for Sedation in Pediatrics

Abstract

To develop a stable chloral hydrate (CH) syrup and to test its clinical efficacy in inducing painless sedation during diagnostic imaging examinations in children under 4 years of age. For the physico-chemical tests, the vials were stored at + 5 and + 25°C and the analysis was carried out for 60 days. The microbiological tests were performed in 4 days of analysis. The prospective clinical study was conducted in 33 infants and children after receiving CH syrup orally for sedation prior to magnetic resonance imaging (MRI). After two months of storage, the average concentrations in all tests were greater than 95% of the initial chloral hydrate concentration. No microbiological growth was noted after 60 days of storage. The clinical use of syrup in children resulted in effective sedation in 100% of children and rare side effects. Compared to midazolam, chloral hydrate is more effective for sedating children under 5 years of age and is significantly less expensive. The prescription of 5% CH syrup for sedation prior to imaging diagnosis has well-established efficacy. However, the safe use of chloral hydrate in infants and children under 5 years of age should be in accordance with international recommendations.