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Published on: January 17, 2011
Clonidine in the sedation of mechanically ventilated children: a pilot randomized trial
Mark Duffett1, Karen Choong1, Jennifer Foster2
1Departments of Pediatrics Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Insights
This pilot study shows that a larger trial on clonidine (a sedative) for critically ill children is feasible. It identified challenges to refine future research protocols and enrollment targets for better outcomes.
Area of Science:
- Pediatric Critical Care Medicine
- Clinical Pharmacology
- Trial Methodology
Background:
- Clonidine is frequently used for sedation in critically ill children.
- Limited rigorous randomized controlled trials exist to evaluate its effectiveness.
- A large-scale trial is needed to establish efficacy and safety.
Purpose of the Study:
- To assess the feasibility of conducting a larger randomized controlled trial (RCT) on clonidine for pediatric sedation.
- Key feasibility metrics included screening, recruitment, drug administration timeliness, and protocol adherence.
Main Methods:
- A randomized, blinded, placebo-controlled pilot trial.
- Mechanically ventilated children received either enteral clonidine (5 μg/kg) or placebo every 6 hours.
- Additional sedatives were administered at the discretion of attending physicians.
Main Results:
- 50 children were enrolled, with a median age of 2.5 years.
- High rates of patient approach (90%) and enrollment within 1 day (70%) were observed.
- 94% of clonidine doses were administered according to the protocol; no significant differences in clinical outcomes or adverse effects were noted between groups.
Conclusions:
- The pilot trial demonstrated the feasibility of a larger RCT for clonidine in pediatric sedation.
- Challenges were identified, enabling protocol refinement and improved enrollment estimates for future studies.
- Results support designing a larger trial focused on clinically significant outcomes, leveraging insights from this pilot.
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.
