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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ben J Pieters, Children's Mercy Hospital Kansas City Identifier:
First received: June 20, 2011
Last updated: January 26, 2016
Last verified: February 2015
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
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: December 2016
Estimated Primary Completion Date: September 2016 (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.

Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01531439

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

Responsible Party: Ben J Pieters, Staff Anesthesiologist, Children's Mercy Hospital Kansas City Identifier: NCT01531439     History of Changes
Other Study ID Numbers: 11 04-059 
Study First Received: June 20, 2011
Last Updated: January 26, 2016
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

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pain, Postoperative
Signs and Symptoms, Digestive
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on July 25, 2016