The Use of Intranasal Ketoralac for Pain Management (Sprix)

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The prevalence and incidence of urolithiasis, or kidney stone disease, are increasing in the general population. Life-time incidence of urolithiasis is estimated to be between 5%- 12%. The treatment of kidney stones depends on stone type and size, symptom severity, and the presence of obstruction.

URS is a common ambulatory procedure as improved technological advances and increased clinical utilization have helped decrease postoperative complications. Despite an overall reduction in the perioperative complication rate, post operative pain management after URS remains a major factor delaying discharge of patients.

Post operative pain after URS is usually treated with opioids and non steroidal anti inflammatory drugs. Intranasal ketorolac (SprixTM) is an FDA approved pain formulation for short term management (5 days) of moderate to moderately severe pain that requires analgesia at the opioid level. The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries.

The primary objective of the study is to evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements. Secondary objectives of the study are to (a) evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery, (b) find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population, (c) find the level of anesthesia satisfaction in the target population, (d) find the time to discharge in the target population, (e) compare the two groups post anesthesia discharge score. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01736358
Study type	Interventional
Source	Montefiore Medical Center
Contact
Status	Terminated
Phase	Phase 4
Start date	October 2012
Completion date	June 2014

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT04746378` - PRedictive Accuracy of Initial Stone Burden Evaluation.
Recruiting	`NCT05100017` - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure	N/A
Recruiting	`NCT04021381` - Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi	Phase 3
Completed	`NCT02266381` - A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy	N/A
Terminated	`NCT01431378` - Pilot Study of Model Based Iterative Reconstruction Using 64-Slice	N/A
Completed	`NCT01451931` - Study of Tomography of Nephrolithiasis Evaluation	Phase 4
Completed	`NCT01295879` - Vitamin D Repletion in Stone Formers With Hypercalciuria	Phase 4
Completed	`NCT02895711` - Radiation Dose of Pediatric Patients During Ureteroscopy
Completed	`NCT05340075` - Staged Bilateral Percutaneous Nephrolithotomy
Recruiting	`NCT03919227` - Measurement of Resistance During UAS Insertion Procedure in RIRS	N/A
Recruiting	`NCT03717285` - Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS	N/A
Completed	`NCT05340088` - Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
Completed	`NCT05032287` - Medical Expulsive Therapy Post-SWL For Renal Stones	N/A
Recruiting	`NCT05701098` - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)	N/A
Not yet recruiting	`NCT04080973` - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia	N/A
Completed	`NCT01792765` - Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach	N/A
Completed	`NCT06211842` - Genetic Variations That Increase the Risk for Calcium Kidney Stones: a Family-based Study
Not yet recruiting	`NCT02214836` - Ultrasound Imaging of Kidney Stones and Lithotripsy	N/A
Not yet recruiting	`NCT04606758` - Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease	N/A
Terminated	`NCT01873690` - Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.