Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Early Morphine Administration on the Development of Acute Opioid Tolerance During Pediatric Scoliosis Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Crawford, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00737997
First received: August 18, 2008
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to examine if morphine administered by bolus before initiating Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as demonstrated by decreased post - operative morphine consumption in children undergoing scoliosis surgery.


Condition Intervention Phase
Scoliosis
Drug: Morphine
Other: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Early Administration of Morphine on the Development of Acute Opioid Tolerance During Infusion of Remifentanil for Pediatric Scoliosis Surgery

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: Every hour for four hours and then every four hours thereafter for 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Propofol and remifentanil consumption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Incidences of post-operative nausea, vomiting, pruritus and pyrexia [ Time Frame: every hour for four hours and then every four hours thereafter for 48 hours ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Other: Saline
10 ml saline alone
Experimental: 2 Drug: Morphine
150 mcg/kg diluted in normal saline to a volume of 10 ml at time of induction of anesthesia

Detailed Description:

At our institution, a study has recently demonstrated that intraoperative infusion of remifentanil is associated with development of clinically relevant acute opioid tolerance in adolescents undergoing scoliosis surgery. This results in increased morphine consumption which in turn is associated with increased incidence of side effects such as respiratory depression, nausea and vomiting, pruritus, ileus and urinary retention. All of these side effects can result in increased consumption of rescue medications with the additional potential for increased duration of patient stay. Any measures that can be introduced to decrease the development of acute opioid tolerance in this patient population would have significant impact on patient morbidity, patient comfort and possibly duration of patient stay.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unpremedicated
  • ASA physical status 1 or 2
  • Aged 11 - 18
  • Scheduled to undergo posterior instrumentation for correction of idiopathic scoliosis

Exclusion Criteria:

  • Chronic opioid use within three months prior to surgery
  • Inability to self-administer morphine using a patient-controlled analgesia (PCA) device
  • Elective postoperative ventilation
  • Obesity (> 130% ideal body weight)
  • Known sensitivity to morphine, remifentanil or any other agent within the standardized protocol
  • Failure to obtain written consent or assent
  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: NCT00737997

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Mark Crawford, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Crawford, Anesthesiologist-In-Chief, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00737997     History of Changes
Other Study ID Numbers: 1000009741
Study First Received: August 18, 2008
Last Updated: November 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Pediatrics
Scoliosis
Morphine
Surgery
Analgesia

Additional relevant MeSH terms:
Scoliosis
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014