Efficacy of Reconstituted Oral Chloral Hydrate from Crystals for Echocardiography Sedation

Background: Chloral hydrate has been the drug of choice for uncooperative infants and children requiring sedation for echocardiography. Recently, the commercially available liquid formulation was discontinued by the manufacturer, and the only oral form of chloral hydrate available was made using reconstituted crystals. The aim of this study was to compare sedation efficacy before and after this change in chloral hydrate formulas. Methods: Consecutive patients presenting for echocardiography sedation during the transition from the manufacturer-derived old formulation to the locally reconstituted new formulation were retrospectively reviewed for time to onset of level 3 sedation, duration of level <= 3 sedation, requirement for additional sedative medications, sedation failure, ability to complete the echocardiographic examination, and adverse events related to the sedatives. Results: The cohort included 124 patients (63 old, 61 new). Although the mean age at sedation was younger for the new group, the weight and average dose of chloral hydrate used were not significantly different. There were no adverse events in either group. Time to onset of sedation was the same between the two formulations, but the duration of sedation was significantly shorter for the new group (42.4 +/- 24.5 vs 55.3 +/- 26.2 min, P = .01). In addition, the need for secondary sedating agents because of inadequate sedation and sedation failure were significantly greater using the new compared with the old formulation. Conclusions: Chloral hydrate reformulation using reconstituted crystals results in a shorter duration of sedation, more frequent requirement for a secondary sedative agent, more frequent sedation failure, and occasional inability to complete the echocardiographic examination compared with the manufacturer's formulation.