Clinical trial NCT00737997: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scoliosis
Keywords: Pediatrics
Scoliosis
Morphine
Surgery
Analgesia
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morphine consumption
timeFrame: Every hour for four hours and then every four hours thereafter for 48 hours
Secondary outcomes:
measure: Propofol and remifentanil consumption
timeFrame: 48 hours
measure: Incidences of post-operative nausea, vomiting, pruritus and pyrexia
timeFrame: every hour for four hours and then every four hours thereafter for 48 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Mark Crawford, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.