Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children

NCT ID: NCT00959062

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Respiration, Artificial; Critical Illness; Conscious Sedation; Deep Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

clonidine

Group Type: EXPERIMENTAL

clonidine

Intervention Type: DRUG

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

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Preparation visually identical to clonidine.

Interventions

clonidine

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

Intervention Type: DRUG

placebo

Preparation visually identical to clonidine.

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark C Duffett

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

McMaster Children's Hospital/Hamilton Health Sciences

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 25015006 (View on PubMed)

Other Identifiers

NIF09213

Identifier Type: -

Identifier Source: org_study_id