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Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy 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. Identifier: NCT02000388
Recruitment Status : Unknown
Verified November 2013 by Citrus Valley Medical Research, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Citrus Valley Medical Research, Inc.

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

Condition or disease Intervention/treatment Phase
Post Vasectomy Pain Drug: Ketorolac Tromethamine Other: Standard of Care Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management Tool for Adult Male Patients With Post-Vasectomy Pain
Study Start Date : February 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Ketorolac tromethamine (SPRIX)
A SPRIX dose will be one 15.75 mg spray in each nostril for a total dose of 31.5 mg which can be repeated every 6-8 hrs as needed for post vasectomy pain with a maximum daily dose of 126 mg to be continued for up to 5 days.
Drug: Ketorolac Tromethamine
Other Name: SPRIX

Standard of care
The intervention used will be standard of care
Other: Standard of Care

Primary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


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


  1. 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)
  2. Use of narcotics/opiate or medical marijuana within one (1) week prior to the baseline visit and entire study participation
  3. Use of illegal drugs by self reporting
  4. History of drug or alcohol abuse within five (5) years of screening visit
  5. History of suicide attempt within five (5) years of screening visit
  6. A diagnosis of a severe neuro-psychiatric disease
  7. 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
  8. 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
  9. Resting, sitting blood pressure (BP) > 160mm Hg in systolic pressure or > 100mm Hg is diastolic pressure at screening. If a patient is found to have untreated significant hypertension at screening and antihypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least one month. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least one month prior to screening.
  10. Known or suspected cerebrovascular bleeding, hemorrhagic diathesis or incomplete hemostasis, and those at high risk of bleeding, have history of a bleeding problem or low platelet count or coagulation disorder or are on therapy that affects homeostasis
  11. Active peptic ulcer disease, recent GI bleeding or perforation, or a history of peptic ulcers or GI bleeding
  12. History of asthma, urticaria or other allergic-type reaction after taking aspirin or other non steroidal inflammatory drugs (NASIDs)
  13. Subject over sixty four (64) years of age
  14. Subject with any clinically significant renal function or liver abnormality
  15. Subject who has history of swelling of face, mouth, tongue, lips, gums, neck, or throat (angioedema) or with cardiac decompensation or similar conditions
  16. Major surgery scheduled within 3 weeks or screening and for entire participation of study
  17. Current exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal necrolysis
  18. Any condition in the opinion of the investigator that makes the subject unsuitable for study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02000388

Sponsors and Collaborators
Citrus Valley Medical Research, Inc.
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Principal Investigator: Edward L Davis, M.D. Citrus Valley Medical Research, Inc.

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Responsible Party: Citrus Valley Medical Research, Inc. Identifier: NCT02000388    
Other Study ID Numbers: 1012-2011-SPRIX
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action