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

NCT00737997 | Completed Phase 3

• 1 other identifier: 1000009741
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

Pediatrics; Scoliosis; Morphine; Surgery; Analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Every hour for four hours and then every four hours thereafter for 48 hours

Secondary Outcomes (2)

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

Other: Saline

2

EXPERIMENTAL

Drug: Morphine

Interventions

Morphine DRUG

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

2

Saline OTHER

10 ml saline alone

1

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Unpremedicated
• ASA physical status 1 or 2
• Aged 11 - 18
• Scheduled to undergo posterior instrumentation for correction of idiopathic scoliosis

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 19050084 DERIVED

MeSH Terms

Conditions

Scoliosis; Agnosia

Interventions

Morphine; Sodium Chloride

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mark Crawford, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist-In-Chief

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2008
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

CA (1)