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

Study Description

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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.

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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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, average 5 days ]
   Scale presented to subject to complete daily
2. Severity of nausea [ Time Frame: Assessed daily while in hospital requiring PCA, average 5 days ]
   Scale presented to subject daily to rate nausea
3. Severity of pain [ Time Frame: Assessed by bedside nurse 3 times daily while requiring PCA ]
   Scale number 0-10

Eligibility Criteria

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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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	February 13, 2012
Last Update Posted:	July 19, 2017
Last Verified:	July 2017

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