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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00488787
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : February 7, 2008
Information provided by:
Javelin Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: intranasal ketamine Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2001
Actual Primary Completion Date : April 2001
Actual Study Completion Date : April 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. total pain relief over 0-3 hours following dosing [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. other pain assessments [ Time Frame: 3 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00488787

Sponsors and Collaborators
Javelin Pharmaceuticals
Principal Investigator: Kyle Christensen, DDS Jean Brown Associates

Responsible Party: Javelin Pharmaceuticals Identifier: NCT00488787     History of Changes
Other Study ID Numbers: KET-003
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: February 7, 2008
Last Verified: February 2008

Keywords provided by Javelin Pharmaceuticals:
2-4 impacted third molars

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action