Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery

Hospira, now a wholly owned subsidiary of Pfizer250 enrolled

Overview

The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Pain, Postoperative

Interventions

PMI-150 (intranasal ketamine)DRUG

PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.

PlaceboDRUG

Placebo (intranasal) at time 0 and scheduled times thereafter.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient is scheduled for elective orthopedic surgery or procedure Exclusion Criteria: * patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study

Locations (16)

Jefferson Clinic

Birmingham, Alabama, United States

Shoals Clinical Research

Florence, Alabama, United States

Outcomes

Primary Outcomes

Measures of pain intensity difference

Time frame: 0-6 hours

Data from ClinicalTrials.gov

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