Status:
COMPLETED
Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
McMaster University
Conditions:
Respiration, Artificial
Critical Illness
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief Summary
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 seda...
Detailed Description
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 seda...
Eligibility Criteria
Inclusion
- aged 1 month to 18 years
- mechanically ventilated
- the attending physician expects to require mechanical ventilation for at least 2 more days
- requires sedation in the form of: morphine by continuous infusion or greater than 4 intermittent doses in the previous 24 hours or fentanyl as a continuous infusion AND midazolam or lorazepam by continuous infusion or more than 3 intermittent doses of lorazepam or 6 doses of midazolam in the previous 12 hours
- has enteral access (gastric or jejunal feeding tube)
Exclusion
- hemodynamically unstable
- meet the American College of Critical Care Medicine hemodynamic definition of shock
- hypotensive or tachycardic
- bradycardia, hemodynamically significant cardiac disease or chronic use of anti-hypertensive or diuretic medications
- a traumatic brain injury on admission
- chronically (defined as routine administration prior to hospital admission or for greater than 7 days in hospital prior to PICU admission) use benzodiazepines or opioids
- have received greater than two doses of clonidine within the previous 2 days or dexmedetomidine in the past 2 days
- were previously enrolled in this study
- are currently enrolled in a related study
- are known to be pregnant or breastfeeding
- are known to be allergic to clonidine or any other ingredient in the tablets or suspension
- are being considered for organ procurement
- were chronically (\>30 days) ventilated prior to PICU admission
- are currently receiving, or are expected to initiate the ketogenic diet
- are receiving cyclosporine or methylphenidate
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00959062
Start Date
January 1 2010
End Date
September 1 2012
Last Update
August 13 2014
Active Locations (2)
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1
McMaster Children's Hospital/Hamilton Health Sciences
Hamilton, Ontario, Canada, L8n 3Z5
2
London Health Sciences Centre
London, Ontario, Canada