Evidence of safety of chloral hydrate for prolonged sedation in PICU in a tertiary teaching hospital in southern Brazil

Eur J Clin Pharmacol. 2009 Dec;65(12):1253-8. doi: 10.1007/s00228-009-0694-8.

Abstract

Objective: To evaluate the utilization of chloral hydrate (CH) for sedation in pediatric intensive care and the incidence of adverse drug reactions.

Methods: This was a cohort study including patients with prescription of chloral hydrate hospitalized in the pediatric intensive care unit (PICU) of a university-affiliated, general, tertiary teaching hospital. Data were collected from a spreadsheet for daily monitoring, and clinical events registered in the patient records were analyzed to evaluate the causality of suspected adverse drug reactions (ADR), applying the Naranjo algorithm.

Results: Three hundred forty-three patients who had been prescribed CH were studied. Ages ranged from 0 to 18 years, and 63% were male. The most frequent cause for PICU admission was bronchiolitis (77.6%), and 58.6% required mechanical ventilation. In 92.7% of cases, CH was indicated to control agitation and in 7.3% for procedural sedation. The median time of CH use was 6 days. The incidence of suspected ADR was 22.7% ± 2.3. Oxygen desaturation was the most frequent adverse event (64.6%), followed by hypotension. Specific treatment was required in 60.9% of the events. Chloral hydrate as cause for suspected ADR was classified as probable in 39 events (35.5%) and as possible in 70 (63.6%), and no event was classified as definite. In the multivariate analysis, only mechanical ventilation was predictive of ADR to CH.

Conclusions: The study described the clinical practice of sedation with CH in the PICU setting of a tertiary teaching hospital in southern Brazil. Data suggest that CH is an alternative for prolonged sedation in PICU

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Brazil
  • Child
  • Child, Preschool
  • Chloral Hydrate / administration & dosage*
  • Chloral Hydrate / adverse effects*
  • Cohort Studies
  • Conscious Sedation / adverse effects*
  • Conscious Sedation / methods
  • Conscious Sedation / statistics & numerical data
  • Female
  • Hospitals, Teaching
  • Humans
  • Hypnotics and Sedatives / administration & dosage*
  • Hypnotics and Sedatives / adverse effects*
  • Infant
  • Intensive Care Units, Pediatric
  • Male

Substances

  • Hypnotics and Sedatives
  • Chloral Hydrate