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

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