Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children

NCT00959062 | Completed Phase 4 DMC

• 1 other identifier: NIF09213
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Pilot Study; Randomized Controlled Trial; Critically Ill; Child; Pediatric; Clonidine; Sedation

Outcome Measures

Primary Outcomes (4)

• Feasibility of screening procedures.

  90 days

• Protocol adherence.

  90 days

• Enrollment rate.

  90 days

• Timeliness of drug administration.

  90 days

Secondary Outcomes (5)

• 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

Study Arms (2)

clonidine

EXPERIMENTAL

Drug: clonidine

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

clonidine DRUG

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

clonidine

placebo DRUG

Preparation visually identical to clonidine.

placebo

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (2)

McMaster Children's Hospital/Hamilton Health Sciences

Hamilton, Ontario, L8n 3Z5, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 25015006 RESULT

MeSH Terms

Conditions

Respiratory Aspiration; Critical Illness

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark C Duffett

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 14, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

CA (2)