Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children
Information source: McMaster University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiration, Artificial; Critical Illness; Conscious Sedation; Deep Sedation
Intervention: clonidine (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hamilton Health Sciences Corporation Official(s) and/or principal investigator(s):
Mark C Duffett, Principal Investigator, Affiliation: Hamilton Health Sciences Corporation
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 sedation with the adverse effects associated with sedative medications.
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.
Clinical Details
Official title: New Approaches to Pediatric Sedation: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot Trial)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Feasibility of screening procedures.Protocol adherence. Enrollment rate. Timeliness of drug administration.
Secondary outcome: Sedation and analgesia requirements.Opioid and/or benzodiazepine withdrawal symptoms. Adverse effects. Duration of hospital stay. Ventilator-free days (number of days alive and breathing unaided within the first 28 days after intubation).
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 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.
Eligibility
Minimum age: 1 Month.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
McMaster Children's Hospital/Hamilton Health Sciences, Hamilton, Ontario L8n 3Z5, Canada
London Health Sciences Centre, London, Ontario, Canada
Additional Information
Starting date: January 2010
Last updated: August 11, 2014
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