Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain - Full Text View

Sponsored by:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00488787

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 II

Drug Information available for: Ketamine Ketamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
A: Experimental Intranasal ketamine low dose	Drug: intranasal ketamine low dose
B: Experimental intranasal ketamine medium dose	Drug: intranasal ketamine medium dose
C: Experimental intranasal ketamine high dose	Drug: intranasal ketamine high dose
D: Placebo Comparator 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

Responsible Party:	Javelin Pharmaceuticals ( Javelin Pharmaceuticals )
Study ID Numbers:	KET-003
Study First Received:	June 19, 2007
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00488787
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

dental
surgery
analgesia
2-4 impacted third molars

Study placed in the following topic categories:

Excitatory Amino Acids
Signs and Symptoms
Postoperative Complications
Toothache

Ketamine
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative
Pharmacologic Actions

Pathologic Processes
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009