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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by (Responsible Party):
Ben J Pieters, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01531439
First received: June 20, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Pain, Postoperative
Postoperative Nausea and Vomiting
Scoliosis
Drug: Naloxone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Number of hours until tolerating oral intake [ Time Frame: Assessed daily in hospital while in hospital until taking orals, average 4 days. ] [ Designated as safety issue: No ]
    Defined as time when awakening after surgery until tolerating orals.


Secondary Outcome Measures:
  • Severity of itching [ Time Frame: Assessed daily while in hospital requiring PCA, average 5 days ] [ Designated as safety issue: No ]
    Scale presented to subject to complete daily

  • Severity of nausea [ Time Frame: Assessed daily while in hospital requiring PCA, average 5 days ] [ Designated as safety issue: No ]
    Scale presented to subject daily to rate nausea

  • Severity of pain [ Time Frame: Assessed by bedside nurse 3 times daily while requiring PCA ] [ Designated as safety issue: No ]
    Scale number 0-10


Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naloxone infusion 0.5 mcg/kg/hr Drug: Naloxone
Naloxone infusion 0.5 mcg/kg/hr
Other Name: Narcan
Experimental: Naloxone 2.5 mcg/kg/hr
Naloxone infusion 2.5 mcg/kg/hr
Drug: Naloxone
Naloxone infusion 2.5 mcg/kg/hr
Other Name: Narcan

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

Ages Eligible for Study:   10 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531439

Contacts
Contact: Julia Leamon, RN 816 234 3000 ext 51036 jleamon@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Benjamin J. Pieters, DO Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Ben J Pieters, Staff Anesthesiologist, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01531439     History of Changes
Other Study ID Numbers: 11 04-059
Study First Received: June 20, 2011
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Narcotic Antagonists
Naloxone infusion
Postoperative pruritis
Patient controlled analgesia
Pediatric
Children

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting
Pain
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014