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

Phase 3

Completed

• Conditions: Scoliosis
• Interventions: Other: Saline; Drug: Morphine

• Registration Number: NCT00737997
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-12
• Study Completion: 2008-02
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Saline	-
2	Morphine	-

Primary Outcome Measures

Name	Time	Method
Morphine consumption	Every hour for four hours and then every four hours thereafter for 48 hours

Secondary Outcome Measures

Name	Time	Method
Propofol and remifentanil consumption	48 hours
Incidences of post-operative nausea, vomiting, pruritus and pyrexia	every hour for four hours and then every four hours thereafter for 48 hours

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada