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

NCT03274453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2018-06-14

Study results available
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Summary

The aim of the proposed study is to examine the effectiveness of low dose postoperative ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid naïve patients after major spine surgery. Primary endpoints of the study are to determine the effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain and opioid requirements.

Conditions

  • Spinal Fusion

Interventions

DRUG

Ketamine

0.12 mg/kg/hr of ketamine post surgery

DRUG

Saline

Saline will be administered at the same rate as the ketamine infusion.

Sponsors & Collaborators

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-01
Primary Completion
2014-11-01
Completion
2017-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03274453 on ClinicalTrials.gov