Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot)
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|ClinicalTrials.gov Identifier: NCT00959062|
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Respiration, Artificial Critical Illness Conscious Sedation Deep Sedation||Drug: clonidine Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||New Approaches to Pediatric Sedation: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot Trial)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
5 mcg/kg (maximum 200 mcg) enterally every 6 hours
|Placebo Comparator: placebo||
Preparation visually identical to clonidine.
- Feasibility of screening procedures. [ Time Frame: 90 days ]
- Protocol adherence. [ Time Frame: 90 days ]
- Enrollment rate. [ Time Frame: 90 days ]
- Timeliness of drug administration. [ Time Frame: 90 days ]
- Sedation and analgesia requirements. [ Time Frame: 90 days ]
- Opioid and/or benzodiazepine withdrawal symptoms. [ Time Frame: 90 days ]
- Adverse effects. [ Time Frame: 90 days ]
- Duration of hospital stay. [ Time Frame: 90 days ]
- Ventilator-free days (number of days alive and breathing unaided within the first 28 days after intubation). [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|