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

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.
 
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

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
Pain, Postoperative Postoperative Nausea and Vomiting Scoliosis Drug: Naloxone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2011
Actual Primary Completion Date : May 1, 2015
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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.


  2. 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.


  3. 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.




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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

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
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Benjamin J. Pieters, DO Children's Mercy Hospital Kansas City
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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: February 13, 2012    Key Record Dates
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020
Last Verified: September 2020
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:
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Scoliosis
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents