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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion

NCT02424591

Postoperative Pain

COMPLETED PHASE4

Naloxone Education in Total Joint Patients

NCT04868552

Opioid Use Pain, Musculoskeletal Surgery +1 more

UNKNOWN NA

Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery

NCT06066879

Revision Spine Surgery Fusion of Spine Cervical Fusion +1 more

UNKNOWN PHASE4

Anesthetic Optimization in Scoliosis Surgery

NCT02481570

Adolescent Idiopathic Scoliosis Respiratory Depression Postoperative Pain

COMPLETED NA

A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion

NCT03274453

Spinal Fusion

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative Postoperative Nausea and Vomiting Scoliosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Naloxone infusion 0.5 mcg/kg/hr

Group Type ACTIVE_COMPARATOR

Naloxone

Intervention Type DRUG

Naloxone infusion 0.5 mcg/kg/hr

Naloxone 2.5 mcg/kg/hr

Naloxone infusion 2.5 mcg/kg/hr

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

Naloxone infusion 2.5 mcg/kg/hr

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Naloxone

Naloxone infusion 0.5 mcg/kg/hr

Intervention Type DRUG

Naloxone

Naloxone infusion 2.5 mcg/kg/hr

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Narcan Narcan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No