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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531439
First Posted: February 13, 2012
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ben J Pieters, Children's Mercy Hospital Kansas City
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Ben J Pieters, 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. ]
    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 ]
    Scale presented to subject to complete daily

  • Severity of nausea [ Time Frame: Assessed daily while in hospital requiring PCA, average 5 days ]
    Scale presented to subject daily to rate nausea

  • Severity of pain [ Time Frame: Assessed by bedside nurse 3 times daily while requiring PCA ]
    Scale number 0-10


Enrollment: 84
Actual Study Start Date: November 2011
Study Completion Date: December 1, 2016
Primary Completion Date: May 1, 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531439


Locations
United States, Missouri
Children's Mercy Hospital
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

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
First Submitted: June 20, 2011
First Posted: February 13, 2012
Last Update Posted: July 19, 2017
Last Verified: July 2017

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

Additional relevant MeSH terms:
Vomiting
Scoliosis
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Nausea
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents