ClinicalTrials.Veeva

Menu

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

C

Citrus Valley Medical Research, Inc.

Status and phase

Unknown
Phase 4

Conditions

Post Vasectomy Pain

Treatments

Drug: Ketorolac Tromethamine
Other: Standard of Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02000388
1012-2011-SPRIX

Details and patient eligibility

About

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

Enrollment

15 estimated patients

Sex

Male

Ages

25 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

  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

EXCLUSION CRITERIA

  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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Ketorolac tromethamine (SPRIX)
Other group
Description:
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.
Treatment:
Drug: Ketorolac Tromethamine
Standard of care
Other group
Description:
The intervention used will be standard of care
Treatment:
Other: Standard of Care

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems