Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot)

This study has been completed.
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00959062
First received: August 13, 2009
Last updated: August 11, 2014
Last verified: August 2014

August 13, 2009
August 11, 2014
January 2010
September 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00959062 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children
New Approaches to Pediatric Sedation: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot Trial)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Respiration, Artificial
  • Critical Illness
  • Conscious Sedation
  • Deep Sedation
  • Drug: clonidine
    5 mcg/kg (maximum 200 mcg) enterally every 6 hours
  • Drug: placebo
    Preparation visually identical to clonidine.
  • Experimental: clonidine
    Intervention: Drug: clonidine
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Duffett M, Choong K, Foster J, Cheng J, Meade MO, Menon K, Cook DJ. Clonidine in the sedation of mechanically ventilated children: A pilot randomized trial. J Crit Care. 2014 Jun 11. pii: S0883-9441(14)00235-4. doi: 10.1016/j.jcrc.2014.05.029. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
1 Month to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00959062
NIF09213
Yes
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: Mark C Duffett Hamilton Health Sciences Corporation
McMaster University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP