Back to resultsEffect of Early Morphine Administration on the Development of Acute Opioid Tolerance During Pediatric Scoliosis Surgery
Primary Purpose
Scoliosis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Morphine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis focused on measuring Pediatrics, Scoliosis, Morphine, Surgery, Analgesia
Eligibility 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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Morphine consumption
Secondary Outcome Measures
Propofol and remifentanil consumption
Incidences of post-operative nausea, vomiting, pruritus and pyrexia
Full Information
NCT ID
NCT00737997
First Posted
August 18, 2008
Last Updated
November 18, 2014
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT00737997
Brief Title
Effect of Early Morphine Administration on the Development of Acute Opioid Tolerance During Pediatric Scoliosis Surgery
Official Title
Effect of Early Administration of Morphine on the Development of Acute Opioid Tolerance During Infusion of Remifentanil for Pediatric Scoliosis Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Pediatrics, Scoliosis, Morphine, Surgery, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
150 mcg/kg diluted in normal saline to a volume of 10 ml at time of induction of anesthesia
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
10 ml saline alone
Primary Outcome Measure Information:
Title
Morphine consumption
Time Frame
Every hour for four hours and then every four hours thereafter for 48 hours
Secondary Outcome Measure Information:
Title
Propofol and remifentanil consumption
Time Frame
48 hours
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Crawford, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
19050084
Citation
McDonnell C, Zaarour C, Hull R, Thalayasingam P, Pehora C, Ahier J, Crawford MW. Pre-treatment with morphine does not prevent the development of remifentanil-induced hyperalgesia. Can J Anaesth. 2008 Dec;55(12):813-8. doi: 10.1007/BF03034052.
Results Reference
derived
Learn more about this trial
Effect of Early Morphine Administration on the Development of Acute Opioid Tolerance During Pediatric Scoliosis Surgery
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