N/A N=84 Randomized Quadruple-blind Supportive Care

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

Pain, Postoperative · Postoperative Nausea and Vomiting · Scoliosis

Bottom Line

View on ClinicalTrials.gov: NCT01531439 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Number of Hours Until Tolerating Oral Intake — 25.9; 25.0 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Naloxone (Drug)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Children's Mercy Hospital Kansas City
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Hours Until Tolerating Oral Intake	25.9; 25.0	—
SECONDARY Severity of Itching	2.1; 1.9	—
SECONDARY Severity of Nausea	2.0; 1.2	—
SECONDARY Severity of Pain	3.7; 4.1	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01531439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.