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 itchingSeverity 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
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