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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00488787
First Posted: June 20, 2007
Last Update Posted: February 7, 2008
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.
Information provided by:
Javelin Pharmaceuticals
  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
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

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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00488787


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

Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00488787     History of Changes
Other Study ID Numbers: KET-003
First Submitted: June 19, 2007
First Posted: June 20, 2007
Last Update Posted: February 7, 2008
Last Verified: February 2008

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

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