NCT01531439

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Scoliosis

Interventions

Type	Name	Description
DRUG	Naloxone	Naloxone infusion 0.5 mcg/kg/hr
DRUG	Naloxone	Naloxone infusion 2.5 mcg/kg/hr

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-05-01
• Completion: 2016-12-01
• First posted: 2012-02-13
• Last updated: 2020-09-10
• Results posted: 2020-09-10

Locations

1 site across 1 country: United States