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

NCT01531439 | Completed Results

• 1 other identifier: 11 04-059
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Scoliosis

Keywords

Narcotic Antagonists; Naloxone infusion; Postoperative pruritis; Patient controlled analgesia; Pediatric; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of Itching

  Assessed daily while in hospital requiring PCA

• Severity of Nausea

  Assessed daily while in hospital requiring PCA.

• Severity of Pain

  Assessed by bedside nurse 3 times daily while requiring PCA

Study Arms (2)

Naloxone infusion 0.5 mcg/kg/hr

ACTIVE COMPARATOR

Drug: Naloxone

Naloxone 2.5 mcg/kg/hr

EXPERIMENTAL

Naloxone infusion 2.5 mcg/kg/hr

Drug: Naloxone

Interventions

Naloxone DRUG

Naloxone infusion 0.5 mcg/kg/hr

Also known as: Narcan

Naloxone infusion 0.5 mcg/kg/hr

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Idiopathic scoliosis requiring spine fusion surgery
• Age 10-21 years

You may not qualify if:

• Inability to understand PCA instructions
• Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
• Chronic opioid therapy \> 2 months
• Non-English speaking

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Scoliosis

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr Ben Pieters
• Organization: Children's Mercy Hospital

bjpieters@cmh.edu

816-234-3464

Study Officials

• Benjamin J. Pieters, DO

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: February 13, 2012
• Study Start: November 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 10, 2020
• Results First Posted: September 10, 2020

Record last verified: 2020-09

Locations

US (1)