Purpose: Clonidine is often used as a sedative in critically ill children, but its effectiveness has not been evaluated in a large, rigorous randomized controlled trial. Our objectives in this pilot trial were to assess the feasibility of a larger trial with respect to (1) effective screening, (2) recruitment, (3) timely drug administration, and (4) protocol adherence.
Materials and methods: This is a randomized, blinded, placebo-controlled pilot trial. Mechanically ventilated children received enteral clonidine 5 μg/kg or placebo every 6 hours; additional sedatives were at the discretion of attending physicians.
Results: We enrolled 50 children. The median interquartile range (IQR) age was 2.5 (0.7-5.2) years, and Pediatric Risk of Mortality score on pediatric intensive care unit admission was 12 (8-15). In terms of feasibility outcomes, 90 (87%) of 104 eligible patients were approached for consent, and on average, 1.7 children were enrolled per month. Thirty-five (70%) were enrolled within 1 day of becoming eligible (mean, 1.2 days). Thereafter, 94% of doses were administered by protocol. Clinical outcomes and adverse effects were not significantly different between the groups.
Conclusions: This pilot trial demonstrated feasibility of a larger randomized controlled trial. Some important challenges emerged, allowing refinement of the study protocol and enrolment estimates. We recommend that future trials capitalize on the experience gained and use these results to design a larger trial focusing on clinically important outcomes.
Trial registration: ClinicalTrials.gov NCT00959062.
Keywords: Clonidine; Pediatric critical care; Pilot trial; Randomized controlled trial; Sedation.
Copyright © 2014 Elsevier Inc. All rights reserved.