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Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Ben J Pieters, Children's Mercy Hospital Kansas City.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Children's Mercy Hospital Kansas City
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Ben J Pieters, 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. ]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 ]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
| 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) |
| 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01531439
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 |
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:
|
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 June 23, 2017