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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00737997
Enrollment
40
Registered
2008-08-20
Start date
2006-12-31
Completion date
2008-02-29
Last updated
2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Pediatrics, Scoliosis, Morphine, Surgery, Analgesia

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.

Interventions

DRUGMorphine

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

OTHERSaline

10 ml saline alone

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Morphine consumptionEvery hour for four hours and then every four hours thereafter for 48 hours

Secondary

MeasureTime frame
Propofol and remifentanil consumption48 hours
Incidences of post-operative nausea, vomiting, pruritus and pyrexiaevery hour for four hours and then every four hours thereafter for 48 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026