Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
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Post Vasectomy Pain | Drug: Ketorolac Tromethamine Other: Standard of Care | Phase 4 |
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 |

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.
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Drug: Ketorolac Tromethamine
Other Name: SPRIX
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Standard of care
The intervention used will be standard of care
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Other: Standard of Care |
- Pain Scores on the Visual Analog Scale [ Time Frame: 5 days ]
- To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 Days ]

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Ages Eligible for Study: | 25 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
- 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.
- 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
- Active peptic ulcer disease, recent GI bleeding or perforation, or a history of peptic ulcers or GI bleeding
- History of asthma, urticaria or other allergic-type reaction after taking aspirin or other non steroidal inflammatory drugs (NASIDs)
- Subject over sixty four (64) years of age
- Subject with any clinically significant renal function or liver abnormality
- Subject who has history of swelling of face, mouth, tongue, lips, gums, neck, or throat (angioedema) or with cardiac decompensation or similar conditions
- Major surgery scheduled within 3 weeks or screening and for entire participation of study
- Current exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal necrolysis
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Any condition in the opinion of the investigator that makes the subject unsuitable for study

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 ClinicalTrials.gov identifier (NCT number): NCT02000388
Principal Investigator: | Edward L Davis, M.D. | Citrus Valley Medical Research, Inc. |
Responsible Party: | Citrus Valley Medical Research, Inc. |
ClinicalTrials.gov Identifier: | NCT02000388 History of Changes |
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:
Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics 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 |