title: Clonidine in the sedation of mechanically ventilated children: a pilot randomized trial.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Departments of Pediatrics Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. Electronic address: duffetmc@mcmaster.ca.
authors.forename: Mark
authors.initials: M
authors.lastname: Duffett
authors.affiliation: Departments of Pediatrics Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Karen
authors.initials: K
authors.lastname: Choong
authors.affiliation: Department of Pediatrics, Western University, London, Ontario, Canada.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Foster
authors.affiliation: Biostatistics Unit, St. Joseph's Healthcare Hamilton and Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Ji
authors.initials: J
authors.lastname: Cheng
authors.affiliation: Departments of Pediatrics and Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Maureen O
authors.initials: MO
authors.lastname: Meade
authors.affiliation: Departments of Pediatrics and Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Kusum
authors.initials: K
authors.lastname: Menon
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Cook
mesh_terms: D000293:Adolescent; D000465:Algorithms; D002648:Child; D002675:Child, Preschool; D003000:Clonidine / Q000008:administration & dosage*; D016638:Critical Illness; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D007223:Infant; D015278:Intensive Care Units, Pediatric; D008297:Male; D010865:Pilot Projects; D012121:Respiration, Artificial
chemical_list: D006993:Hypnotics and Sedatives; D003000:Clonidine
keywords: Clonidine; Pediatric critical care; Pilot trial; Randomized controlled trial; Sedation