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

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ClinicalTrials.gov Identifier: NCT01531439
Recruitment Status : Completed
First Posted : February 13, 2012
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ben J Pieters, Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date  ICMJE June 20, 2011
First Posted Date  ICMJE February 13, 2012
Results First Submitted Date  ICMJE August 20, 2020
Results First Posted Date  ICMJE September 10, 2020
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2020)
  • Severity of Itching [ Time Frame: 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.
  • Severity of Nausea [ Time Frame: 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.
  • Severity of Pain [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Official Title  ICMJE Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pain, Postoperative
  • Postoperative Nausea and Vomiting
  • Scoliosis
Intervention  ICMJE
  • Drug: Naloxone
    Naloxone infusion 0.5 mcg/kg/hr
    Other Name: Narcan
  • Drug: Naloxone
    Naloxone infusion 2.5 mcg/kg/hr
    Other Name: Narcan
Study Arms  ICMJE
  • Active Comparator: Naloxone infusion 0.5 mcg/kg/hr
    Intervention: Drug: Naloxone
  • Experimental: Naloxone 2.5 mcg/kg/hr
    Naloxone infusion 2.5 mcg/kg/hr
    Intervention: Drug: Naloxone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2017)
84
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
80
Actual Study Completion Date  ICMJE December 1, 2016
Actual Primary Completion Date May 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531439
Other Study ID Numbers  ICMJE 11 04-059
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ben J Pieters, Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin J. Pieters, DO Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP