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

Efficacy and Safety of Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management Tool for Adult Male Patients With Post-Vasectomy Pain

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

Study Overview

• Status: Unknown
• Conditions: Post Vasectomy Pain
• Intervention / Treatment: Other: Standard of Care; Drug: Ketorolac Tromethamine

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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 Names: SPRIX
OTHER: Standard of care; The intervention used will be standard of care	Other: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Scores on the Visual Analog Scale	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability	5 Days

Collaborators and Investigators

• Sponsor: Citrus Valley Medical Research, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (ESTIMATE): December 4, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 4, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: 1012-2011-SPRIX