Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
intranasal ketamine
intranasal ketamine
intranasal ketamine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring dental, surgery, analgesia, 2-4 impacted third molars
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
A
B
C
D
Arm Description
Intranasal ketamine low dose
intranasal ketamine medium dose
intranasal ketamine high dose
placebo
Outcomes
Primary Outcome Measures
total pain relief over 0-3 hours following dosing
Secondary Outcome Measures
other pain assessments
Full Information
NCT ID
NCT00488787
First Posted
June 19, 2007
Last Updated
February 5, 2008
Sponsor
Javelin Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00488787
Brief Title
Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain
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 Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
April 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Javelin Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
dental, surgery, analgesia, 2-4 impacted third molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Intranasal ketamine low dose
Arm Title
B
Arm Type
Experimental
Arm Description
intranasal ketamine medium dose
Arm Title
C
Arm Type
Experimental
Arm Description
intranasal ketamine high dose
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
intranasal ketamine
Intervention Description
low dose
Intervention Type
Drug
Intervention Name(s)
intranasal ketamine
Intervention Description
medium dose
Intervention Type
Drug
Intervention Name(s)
intranasal ketamine
Intervention Description
high dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
total pain relief over 0-3 hours following dosing
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
other pain assessments
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Christensen, DDS
Organizational Affiliation
Jean Brown Associates
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain
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