Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery

Not Applicable

Completed

• Conditions: Scoliosis; Postoperative Nausea and Vomiting; Pain, Postoperative
• Interventions: Drug: Naloxone

• Registration Number: NCT01531439
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-06-20
• Study Start: 2011-11
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-13
• Primary Completion: 2015-05-01
• Study Completion: 2016-12-01
• Results First Submitted: 2020-08-20
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Results First Posted: 2020-09-10
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Idiopathic scoliosis requiring spine fusion surgery
• Age 10-21 years

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Exclusion Criteria

• Inability to understand PCA instructions
• Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
• Chronic opioid therapy > 2 months
• Non-English speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naloxone infusion 0.5 mcg/kg/hr	Naloxone	-
Naloxone 2.5 mcg/kg/hr	Naloxone	Naloxone infusion 2.5 mcg/kg/hr

Primary Outcome Measures

Name	Time	Method
Number of Hours Until Tolerating Oral Intake	Assessed daily in hospital while in hospital until taking orals, average 4 days.	Defined as time when awakening after surgery until tolerating orals.

Secondary Outcome Measures

Name	Time	Method
Severity of Itching	Assessed daily while in hospital requiring PCA	Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome.; Title of scale "Itching VAS".; Scores were assessed daily for 5 days and an average of the five days was reported.
Severity of Nausea	Assessed daily while in hospital requiring PCA.	Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome.; Name of scale "Nausea VAS".; Scores were assessed daily for 5 days and an average of the five days reported.
Severity of Pain	Assessed by bedside nurse 3 times daily while requiring PCA	Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum.; Name of scale "Pain VAS".; Scores were assessed daily for 5 days and an average of the five days was reported.

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States