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CompletedNCT00709436Updated Jan 11, 2012

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

A Phase 3 interventional study of PMI-150 (intranasal ketamine) and Placebo in Pain, Postoperative, sponsored by Hospira, now a wholly owned subsidiary of Pfizer. Completed at 16 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-01-11.

Sponsored by Hospira, now a wholly owned subsidiary of Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain, Postoperative

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Keywords

  • orthopedic
  • ketamine
  • pain
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 250 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Hospira, now a wholly owned subsidiary of Pfizer is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient is scheduled for elective orthopedic surgery or procedure

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    1

    PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.

    Drug: PMI-150 (intranasal ketamine)

  • Placebo comparator
    2

    Placebo at time 0 and specified time points thereafter.

    Drug: Placebo

Interventions

  • DrugPMI-150 (intranasal ketamine)

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Measures of pain intensity difference

    Time frame: 0-6 hours

07

Study locations

16 sites
  • Jefferson Clinic
    Birmingham, Alabama 35233, United States
  • Shoals Clinical Research
    Florence, Alabama 35630, United States
  • Helen Keller Hospital
    Sheffield, Alabama 25660, United States
  • Arizona Research Center
    Phoenix, Arizona 85023, United States
  • Vertex Clinical Research
    Bakersfield, California CA, United States
  • California Clinical Research
    Davis, California 95616, United States
  • CORE Orthopedic Medical Center
    Encinitas, California 92024, United States
  • JDP Medical
    Aurora, Colorado 80014, United States
  • Southeastern Center for Clinical Research
    Atlanta, Georgia 30350, United States
  • Chesapeake Research Group
    Pasadena, Maryland 21122, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • Allegehny Pain Management
    Altoona, Pennsylvania 16602, United States
  • University Orthopedics
    State College, Pennsylvania 16801, United States
  • Comprehensive Pain Specialists
    Hendersonville, Tennessee 37075, United States
  • Scott and White Memorial Hospital
    Temple, Texas 76508, United States
  • Jean Brown Research
    Salt Lake City, Utah 84117, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00709436
Lead sponsor
Hospira, now a wholly owned subsidiary of Pfizer
Responsible party
Sponsor
First posted
Jul 3, 2008
Start date
Jun 2008
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Jan 11, 2012

Study contacts

Javelin Pharmaceuticals
study director · Javelin Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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