Comparison of Monitored Anesthesia Care Using Remifentanil or Fentanyl for Major Dressing Changes in Burns

This study has been terminated.
Sponsor:
Information provided by:
Montreal Burn Centre
ClinicalTrials.gov Identifier:
NCT00326859
First received: May 16, 2006
Last updated: October 12, 2006
Last verified: October 2006
  Purpose

During their hospitalization, burn patients frequently require dressing changes that may be painful. Deep analgesia and sedation are used but carry the risk of remnant somnolence and other effects of anesthesia such as dizziness and nausea/vomiting. All these side effects may delay refeeding after the procedure, ambulation and physical therapy. Drugs from the opioid class are used to relieve pain during these procedures. Morphine with its slow onset and remnant sedation is difficult to use in these patients. Pro-emetic properties and histamine liberating effects also make this drug non optimal for iterative procedures. Fentanyl, a synthetic opioid with shorter onset and lower incidence of nausea and vomiting, is the standard drug used in dressing changes in burn patients. It is metabolized by hepatic glucoconjugation. Remifentanil, a well known novel opioid, that has a unique metabolism independent from renal or hepatic functions, is metabolized by a non specific esterase. It has a very short half-life (3.5 minutes) and should therefore be administered as a continuous infusion. The investigators hypothesized that the use of remifentanil for daily burn dressing changes is associated with less pain during procedures and faster recovery. Studied patients will be the ones requiring iterative dressing change procedures under sedation. The primary endpoint will be the maximal pain during the procedure. Secondary endpoints will be: average pain during and after the procedure; subjective sensation of comfort; total amount of opioids received; times to feeding after the procedure and ambulation after the procedure; comfort of the procedure according to the nurses; mobilisation according to the physical therapist; and safety of the analgesia technique. The study will be conducted according to the recommendations of the American Society of Anesthesiologists (ASA) that have been endorsed by the Canadian Anaesthetists' Society (CAS). All patients who consent will fast for at least 6 hours before the procedure. The two following regimens will be compared: a bolus infusion of fentanyl, starting with 1 µg/kg, followed by 0.5 µg/kg as needed every 5 to 10 minutes versus continuous infusion of remifentanil adapted to ensure analgesia. The initial dose of remifentanil will be 0.1 µg/kg/min to be adjusted between 0.05 µg/kg/min and 2 µg/kg/min. To allow blinding during the study, patients will receive a double-blinded protocol with sham (normal saline) in one arm. In other words: for each procedure, the patient will always receive boluses, either of fentanyl or saline, and a perfusion, either of remifentanil or saline. According to power calculations, 30 patients will be necessary to achieve the primary end-points. The investigators plan to enroll 40 patients in the study to allow for some drop outs and to increase their statistical power.


Condition Intervention Phase
Burns
Pain
Drug: remifentanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Montreal Burn Centre:

Primary Outcome Measures:
  • maximal pain during the procedure

Secondary Outcome Measures:
  • average pain during the procedure
  • average pain after the procedure
  • subjective sensation of comfort during the procedure
  • total amount of opioids administered
  • sedation after the procedure
  • time to feeding after the procedure
  • time to ambulation after the procedure
  • comfort of the procedure according to the nurses
  • facility of mobilisation according to physical therapist
  • safety of the analgesia technique

Estimated Enrollment: 40
Study Start Date: August 2005
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient requiring at least 2 major dressing changes less than 2 days apart under analgesia and sedation
  • Patient able to provide written consent

Exclusion Criteria:

  • Patient under 18 years old
  • Patient over 85 years old
  • Patient unable to give consent
  • Patient with hepatic failure
  • Patient with predictable or known difficult airway (grade 3 or 4) as determined by senior intensive care unit (ICU) or anesthesia staff
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326859

Locations
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2W1T8
Sponsors and Collaborators
Montreal Burn Centre
Investigators
Principal Investigator: David Bracco, MD Centre Hospitalier de l'Universite de Montreal
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00326859     History of Changes
Other Study ID Numbers: HD05-043
Study First Received: May 16, 2006
Last Updated: October 12, 2006
Health Authority: Canada: Health Canada

Keywords provided by Montreal Burn Centre:
analgesia strategies
pain
extensive dressing change

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 23, 2014