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

August 11, 2014 updated by: Hamilton Health Sciences Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8n 3Z5
        • McMaster Children's Hospital/Hamilton Health Sciences
      • London, Ontario, Canada
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
Preparation visually identical to clonidine.
Experimental: clonidine
Drug: clonidine
5 mcg/kg (maximum 200 mcg) enterally every 6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of screening procedures.
Time Frame: 90 days
90 days
Protocol adherence.
Time Frame: 90 days
90 days
Enrollment rate.
Time Frame: 90 days
90 days
Timeliness of drug administration.
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Sedation and analgesia requirements.
Time Frame: 90 days
90 days
Opioid and/or benzodiazepine withdrawal symptoms.
Time Frame: 90 days
90 days
Adverse effects.
Time Frame: 90 days
90 days
Duration of hospital stay.
Time Frame: 90 days
90 days
Ventilator-free days (number of days alive and breathing unaided within the first 28 days after intubation).
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

McMaster University

Investigators

  • Principal Investigator: Mark C Duffett, Hamilton Health Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIF09213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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