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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737997
First Posted: August 20, 2008
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Crawford, The Hospital for Sick Children
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Mark Crawford, 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 ]

Secondary Outcome Measures:
  • Propofol and remifentanil consumption [ Time Frame: 48 hours ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: November 19, 2014
Last Verified: November 2014

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

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