The Use of Intranasal Ketoralac for Pain Management (Sprix)

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Despite an overall reduction in the perioperative complication rate, post operative pain management after ureteroscopic removal of stones (URS) remains a major factor delaying discharge of patients. The investigators hypothesize that perioperative usage of intranasal ketorolac will provide a reduction in post operative opioid requirements, better post operative pain control, higher anesthesia satisfaction and faster recovery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• Ureteroscopic stone removal surgeries with stenting

• Age ≥ 18 years and < 65 years

• Stable patient with stable vital signs

• Mentally competent and is able to understand consent form

Exclusion Criteria:

• Unstable patients

• Patients with multiple trauma sites

• Patients with allergies to ketorolac or any of the components in the nasal spray preparation

• Patients with active peptic ulcer disease

• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• Renal disease or at risk for renal failure due to volume depletion

• Pregnant or nursing mothers

• Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor)

• Any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert