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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis

Intervention / Treatment
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* Drug: Naloxone
* Drug: Naloxone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naloxone infusion 0.5 mcg/kg/hr<br> | Drug: Naloxone<br>* Naloxone infusion 0.5 mcg/kg/hr<br>* Other names: Narcan;|
| Experimental: Naloxone 2.5 mcg/kg/hr<br>Naloxone infusion 2.5 mcg/kg/hr | Drug: Naloxone<br>* Naloxone infusion 2.5 mcg/kg/hr<br>* Other names: Narcan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hours Until Tolerating Oral Intake | Defined as time when awakening after surgery until tolerating orals. | Assessed daily in hospital while in hospital until taking orals, average 4 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed daily while in hospital requiring PCA | 
| 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. | Assessed daily while in hospital requiring PCA. | 
| 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. | Assessed by bedside nurse 3 times daily while requiring PCA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Narcotic Antagonists, Naloxone infusion, Postoperative pruritis, Patient controlled analgesia, Pediatric, Children