Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain

February 5, 2008 updated by: Javelin Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Efficacy of 10 mg, 30 mg, and 50 mg of Transnasal Ketamine Hydrochloride (PMI-100) for the Treatment of Postoperative Dental Pain

Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3 hours post administration and assess pain intensity and pain relief throughout the 3 hour postoperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy patients at least 16 years of age requiring two or more third molar extractions

Exclusion Criteria:

  • Less than 16 years old
  • Other exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Intranasal ketamine low dose
Drug: intranasal ketamine
low dose
Drug: intranasal ketamine
medium dose
Drug: intranasal ketamine
high dose
Experimental: B
intranasal ketamine medium dose
Drug: intranasal ketamine
low dose
Drug: intranasal ketamine
medium dose
Drug: intranasal ketamine
high dose
Experimental: C
intranasal ketamine high dose
Drug: intranasal ketamine
low dose
Drug: intranasal ketamine
medium dose
Drug: intranasal ketamine
high dose
Placebo Comparator: D
placebo
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total pain relief over 0-3 hours following dosing
Time Frame: 3 hours
3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
other pain assessments
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javelin Pharmaceuticals

Investigators

  • Principal Investigator: Kyle Christensen, DDS, Jean Brown Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

April 1, 2001

Study Completion (Actual)

April 1, 2001

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

February 7, 2008

Last Update Submitted That Met QC Criteria

February 5, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KET-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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