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

This study has been completed.
Information provided by:
Javelin Pharmaceuticals Identifier:
First received: June 19, 2007
Last updated: February 5, 2008
Last verified: February 2008
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 Intervention Phase
Pain, Postoperative
Drug: intranasal ketamine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • total pain relief over 0-3 hours following dosing [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • other pain assessments [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2001
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00488787

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

No publications provided

Responsible Party: Javelin Pharmaceuticals Identifier: NCT00488787     History of Changes
Other Study ID Numbers: KET-003 
Study First Received: June 19, 2007
Last Updated: February 5, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 10, 2016