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

This study has been completed.
Sponsor:
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00488787
First received: June 19, 2007
Last updated: February 5, 2008
Last verified: February 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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
placebo
 Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488787

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

No publications provided

Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov 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:
dental
surgery
analgesia
2-4 impacted third molars

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

ClinicalTrials.gov processed this record on June 17, 2013