Intra-nasal Ketorolac Versus Oral Diclofenac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
University of Texas Southwestern Medical Center
Summary
Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents. Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two non-steroidal anti-inflammatory drugs, intra-nasal Ketorolac versus oral Diclofenac. Hypotheses: Due to its favorable pharmacokinetics in relieving acute pain, investigators expect improved pain scores and a lower rate of unplanned clinical encounters in patients receiving intra-nasal ketorolac compared to those taking oral diclofenac following ureteroscopic surgery for urolithiasis. Study Rationale: Following ureteroscopic management of urolithiasis, patient with indwelling ureter stents have higher levels of discomfort compared to those without a ureter stent. Prior studies showed that intramuscular Ketorolac at time of ureter stent removal decreased the incidence of unplanned clinical encounters. Furthermore, onset of analgesic effect by intra-nasal ketorolac is faster than its oral form, and similar its intramuscular and intravenous counterparts.
Description
Urinary stone disease (USD) leads to pain, diminished quality of life, missed work and school, chronic kidney disease, and renal failure.1-5 The prevalence of kidney stone disease in adults has risen to almost 9% as of 2010 in the United States (US). The 5-year recurrence rate without treatment is 53%.6,7 Increasing utilization of a ureteroscopic approach to treat urolithiasis has led to an increased proportion of stone patients undergoing ureteral stent placement. In the US, approximately 90% of patients receive a ureteral stent following ureteroscopy. Some patients that undergo ureteral ste…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ≥18 years old * English-speaking * Candidate for unilateral ureteroscopy for treatment of urolithiasis * Surgical plan includes placement of a ureteral stent Exclusion Criteria: * Pregnant/nursing, prisoners, cognitively impaired * Solitary kidney * Stone in transplant kidney * Anatomic abnormalities (i.e., ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, duplicated system) * History of ureteral reconstruction * History of nephrocalcinosis, medullary sponge kidney, cystinuria * Immobility or relative immobility * Planned…
Interventions
- Drugintra-nasal ketorolac
Experimental group receiving intra-nasal ketorolac for management of post-operative pain following ureteroscopy for kidney stone, and associated ureter stent discomfort.
- Drugoral diclofenac
Control group to receive oral diclofenac, which is a comparable medication to intra-nasal ketorolac.
Location
- UT Southwestern Medical CenterDallas, Texas