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: October 16, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Respiration, Artificial
Critical Illness
Conscious Sedation
Deep Sedation
Drug: clonidine
Drug: placebo
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clonidine Drug: clonidine
5 mcg/kg (maximum 200 mcg) enterally every 6 hours
Placebo Comparator: placebo Drug: placebo
Preparation visually identical to clonidine.

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

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959062

Locations
Canada, Ontario
McMaster Children's Hospital/Hamilton Health Sciences
Hamilton, Ontario, Canada, L8n 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Investigators
Principal Investigator: Mark C Duffett Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00959062     History of Changes
Other Study ID Numbers: NIF09213
Study First Received: August 13, 2009
Last Updated: October 16, 2012
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Pilot Study
Randomized Controlled Trial
Critically Ill
Child
Pediatric
Clonidine
Sedation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014