NAPS Pilot: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT00959062

Collaborator

McMaster University (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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)

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: clonidine

Drug: clonidine

5 mcg/kg (maximum 200 mcg) enterally every 6 hours

Placebo Comparator: placebo

Drug: placebo

Preparation visually identical to clonidine.

Outcome Measures

Primary Outcome Measures

Feasibility of screening procedures. [90 days]
Protocol adherence. [90 days]
Enrollment rate. [90 days]
Timeliness of drug administration. [90 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts 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