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

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.
 
ClinicalTrials.gov Identifier: NCT00488787
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : February 7, 2008
Sponsor:
Information provided by:
Javelin Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 19, 2007
First Posted Date  ICMJE June 20, 2007
Last Update Posted Date February 7, 2008
Study Start Date  ICMJE March 2001
Actual Primary Completion Date April 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
total pain relief over 0-3 hours following dosing [ Time Frame: 3 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2007)
total pain relief over 0-3 hours following dosing
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
other pain assessments [ Time Frame: 3 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2007)
other pain assessments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: intranasal ketamine
    low dose
  • Drug: intranasal ketamine
    medium dose
  • Drug: intranasal ketamine
    high dose
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: A
    Intranasal ketamine low dose
    Intervention: Drug: intranasal ketamine
  • Experimental: B
    intranasal ketamine medium dose
    Intervention: Drug: intranasal ketamine
  • Experimental: C
    intranasal ketamine high dose
    Intervention: Drug: intranasal ketamine
  • Placebo Comparator: D
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2007)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2001
Actual Primary Completion Date April 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00488787
Other Study ID Numbers  ICMJE KET-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javelin Pharmaceuticals
Study Sponsor  ICMJE Javelin Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyle Christensen, DDS Jean Brown Associates
PRS Account Javelin Pharmaceuticals
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP