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

Information source: Children's Mercy Hospital Kansas City
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain, Postoperative; Postoperative Nausea and Vomiting; Scoliosis

Intervention: Naloxone (Drug); Naloxone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Children's Mercy Hospital Kansas City

Official(s) and/or principal investigator(s):
Benjamin J. Pieters, DO, Principal Investigator, Affiliation: Children's Mercy Hospital

Overall contact:
Julia Leamon, RN, Phone: 816 234 3000, Ext: 51036, Email: jleamon@cmh.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Number of hours until tolerating oral intake

Secondary outcome:

Severity of itching

Severity of nausea

Severity of pain

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.

Eligibility

Minimum age: 10 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Julia Leamon, RN, Phone: 816 234 3000, Ext: 51036, Email: jleamon@cmh.edu

Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Additional Information

Starting date: June 2011
Last updated: February 4, 2015

Page last updated: August 23, 2015

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