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

Study Overview
=================
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.

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

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Drug: Morphine
* Other: Saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Other: Saline<br>* 10 ml saline alone<br>|
| Experimental: 2<br> | Drug: Morphine<br>* 150 mcg/kg diluted in normal saline to a volume of 10 ml at time of induction of anesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption |  | Every hour for four hours and then every four hours thereafter for 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics, Scoliosis, Morphine, Surgery, Analgesia