Overview

This trial is active, not recruiting.

Conditions pain, postoperative, postoperative nausea and vomiting, scoliosis
Treatments naloxone
Sponsor Children's Mercy Hospital Kansas City
Start date June 2011
End date September 2016
Trial size 80 participants
Trial identifier NCT01531439, 11 04-059

Summary

There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
naloxone Narcan
Naloxone infusion 0.5 mcg/kg/hr
(Experimental)
Naloxone infusion 2.5 mcg/kg/hr
naloxone Narcan
Naloxone infusion 2.5 mcg/kg/hr

Primary Outcomes

Measure
Number of hours until tolerating oral intake
time frame: Assessed daily in hospital while in hospital until taking orals, average 4 days.

Secondary Outcomes

Measure
Severity of itching
time frame: Assessed daily while in hospital requiring PCA, average 5 days
Severity of nausea
time frame: Assessed daily while in hospital requiring PCA, average 5 days
Severity of pain
time frame: Assessed by bedside nurse 3 times daily while requiring PCA

Eligibility Criteria

Male or female participants from 10 years up to 21 years old.

Inclusion Criteria: - Idiopathic scoliosis requiring spine fusion surgery - Age 10-21 years Exclusion Criteria: - Inability to understand PCA instructions - Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine - Chronic opioid therapy > 2 months - Non-English speaking

Additional Information

Official title Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Principal investigator Benjamin J. Pieters, DO
Description Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City.