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

Primary Purpose

Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naloxone
Naloxone
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Narcotic Antagonists, Naloxone infusion, Postoperative pruritis, Patient controlled analgesia, Pediatric, Children

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Naloxone infusion 0.5 mcg/kg/hr

Naloxone 2.5 mcg/kg/hr

Arm Description

Naloxone infusion 2.5 mcg/kg/hr

Outcomes

Primary Outcome Measures

Number of Hours Until Tolerating Oral Intake
Defined as time when awakening after surgery until tolerating orals.

Secondary Outcome Measures

Severity of Itching
Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome. Title of scale "Itching VAS". Scores were assessed daily for 5 days and an average of the five days was reported.
Severity of Nausea
Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome. Name of scale "Nausea VAS". Scores were assessed daily for 5 days and an average of the five days reported.
Severity of Pain
Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum. Name of scale "Pain VAS". Scores were assessed daily for 5 days and an average of the five days was reported.

Full Information

First Posted
June 20, 2011
Last Updated
September 9, 2020
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT01531439
Brief Title
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Official Title
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
May 1, 2015 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis
Keywords
Narcotic Antagonists, Naloxone infusion, Postoperative pruritis, Patient controlled analgesia, Pediatric, Children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naloxone infusion 0.5 mcg/kg/hr
Arm Type
Active Comparator
Arm Title
Naloxone 2.5 mcg/kg/hr
Arm Type
Experimental
Arm Description
Naloxone infusion 2.5 mcg/kg/hr
Intervention Type
Drug
Intervention Name(s)
Naloxone
Other Intervention Name(s)
Narcan
Intervention Description
Naloxone infusion 0.5 mcg/kg/hr
Intervention Type
Drug
Intervention Name(s)
Naloxone
Other Intervention Name(s)
Narcan
Intervention Description
Naloxone infusion 2.5 mcg/kg/hr
Primary Outcome Measure Information:
Title
Number of Hours Until Tolerating Oral Intake
Description
Defined as time when awakening after surgery until tolerating orals.
Time Frame
Assessed daily in hospital while in hospital until taking orals, average 4 days.
Secondary Outcome Measure Information:
Title
Severity of Itching
Description
Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome. Title of scale "Itching VAS". Scores were assessed daily for 5 days and an average of the five days was reported.
Time Frame
Assessed daily while in hospital requiring PCA
Title
Severity of Nausea
Description
Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome. Name of scale "Nausea VAS". Scores were assessed daily for 5 days and an average of the five days reported.
Time Frame
Assessed daily while in hospital requiring PCA.
Title
Severity of Pain
Description
Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum. Name of scale "Pain VAS". Scores were assessed daily for 5 days and an average of the five days was reported.
Time Frame
Assessed by bedside nurse 3 times daily while requiring PCA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin J. Pieters, DO
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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