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

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT01531439
Collaborator
(none)
84
1
2
61
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
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
Actual Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Naloxone infusion 0.5 mcg/kg/hr

Drug: Naloxone
Naloxone infusion 0.5 mcg/kg/hr
Other Names:
  • 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 Names:
  • Narcan
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Hours Until Tolerating Oral Intake [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

    1. Severity of Itching [Assessed daily while in hospital requiring PCA]

      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.

    2. Severity of Nausea [Assessed daily while in hospital requiring PCA.]

      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.

    3. Severity of Pain [Assessed by bedside nurse 3 times daily while requiring PCA]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 21 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 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 Kansas City

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ben J Pieters, Staff Anesthesiologist, Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT01531439
    Other Study ID Numbers:
    • 11 04-059
    First Posted:
    Feb 13, 2012
    Last Update Posted:
    Sep 10, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Ben J Pieters, Staff Anesthesiologist, Children's Mercy Hospital Kansas City
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Arm/Group Description Naloxone: Naloxone infusion 0.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
    Period Title: Overall Study
    STARTED 41 43
    COMPLETED 37 42
    NOT COMPLETED 4 1

    Baseline Characteristics

    Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr Total
    Arm/Group Description Naloxone: Naloxone infusion 0.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr Total of all reporting groups
    Overall Participants 37 42 79
    Age (Count of Participants)
    <=18 years
    37
    100%
    42
    100%
    79
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    34
    91.9%
    37
    88.1%
    71
    89.9%
    Male
    3
    8.1%
    5
    11.9%
    8
    10.1%
    Region of Enrollment (participants) [Number]
    United States
    37
    100%
    41
    97.6%
    78
    98.7%

    Outcome Measures

    1. Primary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Arm/Group Description Naloxone: Naloxone infusion 0.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
    Measure Participants 37 42
    Median (Inter-Quartile Range) [hours]
    25.9
    25.0
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Arm/Group Description Naloxone: Naloxone infusion 0.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
    Measure Participants 37 42
    Median (Inter-Quartile Range) [score on a scale, averaged]
    2.1
    1.9
    3. Secondary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Arm/Group Description Naloxone: Naloxone infusion 0.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
    Measure Participants 37 42
    Median (Inter-Quartile Range) [score on a scale, averaged]
    2.0
    1.2
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Arm/Group Description Naloxone: Naloxone infusion 0.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
    Measure Participants 37 42
    Median (Inter-Quartile Range) [units on a scale, averaged]
    3.7
    4.1

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Arm/Group Description Naloxone: Naloxone infusion 0.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
    All Cause Mortality
    Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/42 (0%)
    Serious Adverse Events
    Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/42 (0%)
    Other (Not Including Serious) Adverse Events
    Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/42 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr Ben Pieters
    Organization Children's Mercy Hospital
    Phone 816-234-3464
    Email bjpieters@cmh.edu
    Responsible Party:
    Ben J Pieters, Staff Anesthesiologist, Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT01531439
    Other Study ID Numbers:
    • 11 04-059
    First Posted:
    Feb 13, 2012
    Last Update Posted:
    Sep 10, 2020
    Last Verified:
    Sep 1, 2020