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

NCT ID: NCT00737997

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

10 ml saline alone

2

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

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

Interventions

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Morphine

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

Intervention Type DRUG

Saline

10 ml saline alone

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Mark Crawford

Anesthesiologist-In-Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Crawford, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 19050084 (View on PubMed)

Other Identifiers

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1000009741

Identifier Type: -

Identifier Source: org_study_id