Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children - Full Text View

Sponsor:	Hamilton Health Sciences Corporation
Collaborator:	McMaster University
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00959062

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 IV

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:

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	January 2010
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	January 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

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

Contacts

Contact: Mark C Duffett

905-521-2100 ext 75216

duffett@hhsc.ca

Locations

Canada, Ontario
McMaster Children's Hospital/Hamilton Health Sciences	Recruiting
Hamilton, Ontario, Canada, L8n 3Z5
Contact: Mark C Duffett
Principal Investigator: Mark C Duffett
Sub-Investigator: Karen Choong

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:	Mark Duffett, McMaster University
ClinicalTrials.gov Identifier:	NCT00959062 History of Changes
Other Study ID Numbers:	NIF09213
Study First Received:	August 13, 2009
Last Updated:	July 19, 2011
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 February 09, 2012