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

Phase 4

• Conditions: Post Vasectomy Pain
• Interventions: Drug: Ketorolac Tromethamine; Other: Standard of Care

• Registration Number: NCT02000388
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Status Verified: 2013-11
• Study First Submitted: 2013-11-19
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted QC: 2013-12-03
• Last Update Submitted: 2013-12-03
• Study First Posted: 2013-12-04
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac tromethamine (SPRIX)	Ketorolac Tromethamine	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.
Standard of care	Standard of Care	The intervention used will be standard of care

Primary Outcome Measures

Name	Time	Method
Pain Scores on the Visual Analog Scale	5 days

Secondary Outcome Measures

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