Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||New Approaches to Pediatric Sedation: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot Trial)|
- Feasibility of screening procedures. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Protocol adherence. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Enrollment rate. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Timeliness of drug administration. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Sedation and analgesia requirements. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Opioid and/or benzodiazepine withdrawal symptoms. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Adverse effects. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Duration of hospital stay. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Ventilator-free days (number of days alive and breathing unaided within the first 28 days after intubation). [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
5 mcg/kg (maximum 200 mcg) enterally every 6 hours
|Placebo Comparator: placebo||
Preparation visually identical to clonidine.
Almost all critically ill children who are mechanically ventilated require sedation and analgesia. Providing effective sedation for children in the PICU requires careful balancing of the need for sedation with the adverse effects associated with sedative medications. Inadequate sedation may result in undue pain and suffering for children, ventilator dysynchrony and may risk removal of life sustaining devices. Excess sedation limits patients' interaction with their parents and care-givers and may result in delayed weaning from mechanical ventilation, prolonged PICU stay and the attendant risks of increased morbidity. Critically ill children may also experience withdrawal when these medications are stopped. Randomized trails in adults have shown that sedation related interventions can improve patients outcomes, but such trials have not been performed in children.
Clonidine is often used as an adjunctive sedative and analgesic in children but a well designed and adequately powered randomized trial is required to test the effect of clonidine-based sedation. Because there are no large randomized trials of sedation related interventions among critically ill children there are many unknown factors.
This pilot trial, focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a larger randomized controlled trial which will focus on clinically important outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959062
|McMaster Children's Hospital/Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8n 3Z5|
|London Health Sciences Centre|
|London, Ontario, Canada|
|Principal Investigator:||Mark C Duffett||Hamilton Health Sciences Corporation|