Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
- Conditions
- Pain, Postoperative
- Interventions
- Drug: PMI-150 (intranasal ketamine)Drug: Placebo
- Registration Number
- NCT00709436
- Lead Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Brief Summary
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.
- Detailed Description
Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- patient is scheduled for elective orthopedic surgery or procedure
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 PMI-150 (intranasal ketamine) PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter. 2 Placebo Placebo at time 0 and specified time points thereafter.
- Primary Outcome Measures
Name Time Method Measures of pain intensity difference 0-6 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
JDP Medical
🇺🇸Aurora, Colorado, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Jefferson Clinic
🇺🇸Birmingham, Alabama, United States
Shoals Clinical Research
🇺🇸Florence, Alabama, United States
Comprehensive Pain Specialists
🇺🇸Hendersonville, Tennessee, United States
Helen Keller Hospital
🇺🇸Sheffield, Alabama, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
California Clinical Research
🇺🇸Davis, California, United States
CORE Orthopedic Medical Center
🇺🇸Encinitas, California, United States
Chesapeake Research Group
🇺🇸Pasadena, Maryland, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Southeastern Center for Clinical Research
🇺🇸Atlanta, Georgia, United States
Allegehny Pain Management
🇺🇸Altoona, Pennsylvania, United States
Vertex Clinical Research
🇺🇸Bakersfield, California, United States
University Orthopedics
🇺🇸State College, Pennsylvania, United States