Efficacy of Reconstituted Oral Chloral Hydrate from Crystals for Echocardiography Sedation

Abstract

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. Objective To compare sedation efficacy before and after this change in chloral hydrate formulas. Methods Consecutive patients presenting for echo sedation during the transition from the manufacturer-derived old formulation (OLD) to the locally-reconstituted new formulation (NEW) 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 echocardiogram 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 2 formulations, but the duration of sedation was significantly shorter for the NEW group (42.4±24.5 vs. 55.3±26.2 min, p=0.01). In addition, the need for secondary sedating agents because of inadequate sedation and sedation failure were significantly greater using the NEW compared to the OLD formulation. Conclusion 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 echocardiogram compared to the manufacturers' formulation.

Comparative Effectiveness of Intranasal Dexmedetomidine–Midazolam versus Oral Chloral Hydrate Targeting Moderate Sedation during Pediatric Transthoracic Echocardiograms

“…Finally, two different formulations of CH were used during the study period. Hill et al 21 recently presented data suggesting that the reconstituted crystalline CH was less effective in sedating pediatric patients for TTE; we did not find this difference in our population. We encountered failure to sedate adequately in 6/31 (19.4%) patients using the commercial syrup and only 1/18 (5.6%) patients who received the reconstituted crystalline product (p ¼ 0.238).…”

Comparison of chloral hydrate and pentobarbital sedation for pediatric echocardiography

“…Some pharmacies are able to compound an oral suspension of CH from crystals or powder forms available from pharmaceutical supply companies. Hill et al compared the previously available commercial formulation of CH to the locally compounded formulation, when used for pediatric sedation during echocardiographic examination and noted that the compounded drug resulted in a shorter duration of sedation, more frequent need for the use of a secondary sedation agent (increasing the risk of adverse events) and more frequent sedation failure. Some centers have advocated using midazolam and inhaled anesthetics.…”

Chloral Hydrate Sedation in a Dexmedetomidine Era

“…However, pharmacies continue to compound an oral suspension from raw crystals or powders. 20 At our institution, the liquid suspension is reconstituted from the rectal formulation and requires twice the volume of the former commercial product. Thus, adverse effects such as emesis may be increased, and there is some evidence for decreased efficacy of compounded chloral hydrate when compared with the commercial product.…”

“…Thus, adverse effects such as emesis may be increased, and there is some evidence for decreased efficacy of compounded chloral hydrate when compared with the commercial product. 20 In light of changes in availability and reports of adverse effects, many institutions have been increasingly using alternative sedatives. We sought to evaluate our institutional use of chloral hydrate as the primary agent for procedural sedation.…”