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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737997
• Other study ID #: 1000009741
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2008
• Last updated: November 18, 2014
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: November 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scoliosis

Intervention

Drug:
• Morphine
150 mcg/kg diluted in normal saline to a volume of 10 ml at time of induction of anesthesia

Other:
• Saline
10 ml saline alone

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption		Every hour for four hours and then every four hours thereafter for 48 hours	No
Secondary	Propofol and remifentanil consumption		48 hours	No
Secondary	Incidences of post-operative nausea, vomiting, pruritus and pyrexia		every hour for four hours and then every four hours thereafter for 48 hours	No