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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Scoliosis; Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Naloxone; Drug: Naloxone

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: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Naloxone infusion 0.5 mcg/kg/hr	Drug: Naloxone; Naloxone infusion 0.5 mcg/kg/hr; Other Names: Narcan; Drug: Naloxone; Naloxone infusion 2.5 mcg/kg/hr; Other Names: Narcan
Experimental: Naloxone 2.5 mcg/kg/hr; Naloxone infusion 2.5 mcg/kg/hr	Drug: Naloxone; Naloxone infusion 0.5 mcg/kg/hr; Other Names: Narcan; Drug: Naloxone; Naloxone infusion 2.5 mcg/kg/hr; Other Names: Narcan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Benjamin J. Pieters, DO, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimate): February 13, 2012

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Children; Pediatric; Narcotic Antagonists; Naloxone infusion; Postoperative pruritis; Patient controlled analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Nausea; Pain, Postoperative; Vomiting; Scoliosis; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: 11 04-059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No