UnknownPhase 4

Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain

15 participantsStarted 2012-02

Plain-language summary

To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine (SPRIX) as an option for pain management in post vasectomy patients.

Who can participate

Age range25 Years – 64 Years

SexMALE

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Inclusion criteria

✓. Male Subject must be between the age twenty five (25) years and sixty four (64)
✓. Willing and able to provide an informed consent
✓. Has made decision to undergo vasectomy
✓. Subject is in good general physical condition as assessed by the Principal Investigator

Exclusion criteria

✕. Current treatment with or known allergy or sensitivity to all forms of ketorolac tromethamine , aspirin , other non steroidal anti inflammatory drugs (NSAIDs) or Ethylenediaminetetraacetic acid (EDTA)
✕. Use of narcotics/opiate or medical marijuana within one (1) week prior to the baseline visit and entire study participation
✕. Use of illegal drugs by self reporting
✕. History of drug or alcohol abuse within five (5) years of screening visit
✕. History of suicide attempt within five (5) years of screening visit
✕. A diagnosis of a severe neuro-psychiatric disease
✕. Subject who is currently receiving investigational drug(s) or participated in a clinical trial involving investigational drug(s) within thirty (30) day of the screening visit
✕. Subject with history of any of the following coronary conditions: (chronic stable angina being currently treated with long acting nitrates, chronic stable angina require treatment with short acting nitrates with 90 days of visit 1, angina occurring during sexual intercourse in the last six months, unstable angina within six months of visit 1

What they're measuring

Pain Scores on the Visual Analog Scale

Timeframe: 5 days

Trial details

NCT IDNCT02000388

SponsorCitrus Valley Medical Research, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Post Vasectomy Pain trials