The Use of Intranasal Ketoralac for Pain Management (Sprix)
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Postoperative Pain Management, Urolithiasis
In brief
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.
Key facts
- Study ID
- NCT01736358
- Run by
- Montefiore Medical Center
- People needed
- 50
- Starts
- 2012-10-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2020-02-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Montefiore Medical Center- Weiler Division — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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