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

Primary Purpose

Respiration, Artificial, Critical Illness, Conscious Sedation

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
clonidine
placebo
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiration, Artificial focused on measuring Pilot Study, Randomized Controlled Trial, Critically Ill, Child, Pediatric, Clonidine, Sedation

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster Children's Hospital/Hamilton Health Sciences
  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

clonidine

placebo

Arm Description

Outcomes

Primary Outcome Measures

Feasibility of screening procedures.
Protocol adherence.
Enrollment rate.
Timeliness of drug administration.

Secondary Outcome Measures

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).

Full Information

First Posted
August 13, 2009
Last Updated
August 11, 2014
Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT00959062
Brief Title
Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children
Acronym
NAPS Pilot
Official Title
New Approaches to Pediatric Sedation: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial, Critical Illness, Conscious Sedation, Deep Sedation
Keywords
Pilot Study, Randomized Controlled Trial, Critically Ill, Child, Pediatric, Clonidine, Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clonidine
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
clonidine
Intervention Description
5 mcg/kg (maximum 200 mcg) enterally every 6 hours
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Preparation visually identical to clonidine.
Primary Outcome Measure Information:
Title
Feasibility of screening procedures.
Time Frame
90 days
Title
Protocol adherence.
Time Frame
90 days
Title
Enrollment rate.
Time Frame
90 days
Title
Timeliness of drug administration.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Sedation and analgesia requirements.
Time Frame
90 days
Title
Opioid and/or benzodiazepine withdrawal symptoms.
Time Frame
90 days
Title
Adverse effects.
Time Frame
90 days
Title
Duration of hospital stay.
Time Frame
90 days
Title
Ventilator-free days (number of days alive and breathing unaided within the first 28 days after intubation).
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C Duffett
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital/Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8n 3Z5
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25015006
Citation
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 Oct;29(5):758-63. doi: 10.1016/j.jcrc.2014.05.029. Epub 2014 Jun 11.
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Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children

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