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

This study is ongoing, but not recruiting participants.

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: January 26, 2016

Last verified: February 2015

History of Changes

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:

MedlinePlus related topics: Nausea and Vomiting Scoliosis

Drug Information available for: Naloxone hydrochloride Naloxone

U.S. FDA Resources

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.

Eligibility


Ages Eligible for Study:	10 Years to 21 Years (Child, Adult)
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

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
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 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

ClinicalTrials.gov processed this record on September 28, 2016

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