Clinical trial NCT00709436: Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
Official title: Randomized, Multiple-center, Double-blind, Placebo-controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-operative Pain Following Orthopedic Trauma, Injury, or Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: orthopedic
ketamine
pain
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measures of pain intensity difference
timeFrame: 0-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Jefferson Clinic
state: Alabama
city: Florence
country: United States
facility: Shoals Clinical Research
state: Alabama
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Bakersfield
country: United States
facility: Vertex Clinical Research
state: California
city: Davis
country: United States
facility: California Clinical Research
state: California
city: Encinitas
country: United States
facility: CORE Orthopedic Medical Center
state: California
city: Aurora
country: United States
facility: JDP Medical
state: Colorado
city: Atlanta
country: United States
facility: Southeastern Center for Clinical Research
state: Georgia
city: Pasadena
country: United States
facility: Chesapeake Research Group
state: Maryland
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Altoona
country: United States
facility: Allegehny Pain Management
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics
state: Pennsylvania
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists
state: Tennessee
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Javelin Pharmaceuticals
name: Javelin Pharmaceuticals
role: STUDY_DIRECTOR
References: