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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
Javelin Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 19, 2007
    Last Updated
    February 5, 2008
    Sponsor
    Javelin Pharmaceuticals
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    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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