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Completed

NCT Number: NCT00737997

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

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.

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Key information

Conditions

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

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

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

Saline

Other

10 ml saline alone

Primary outcomes

  1. Morphine consumption

    Time frame: Every hour for four hours and then every four hours thereafter for 48 hours

Secondary outcomes

  1. Propofol and remifentanil consumption

    Time frame: 48 hours

  2. Incidences of post-operative nausea, vomiting, pruritus and pyrexia

    Time frame: every hour for four hours and then every four hours thereafter for 48 hours

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Aug 20, 2008
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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