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.
≥18 years old
English-speaking
Candidate for unilateral ureteroscopy for treatment of urolithiasis
Surgical plan includes placement of a ureteral stent
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)
Parallel
intra-nasal ketorolac
DrugExperimental group receiving intra-nasal ketorolac for management of post-operative pain following ureteroscopy for kidney stone, and associated ureter stent discomfort.
oral diclofenac
DrugControl group to receive oral diclofenac, which is a comparable medication to intra-nasal ketorolac.
Change in pain scores as measured by USSQ Pain Survey
Associated pain burden will be measured using standardized Ureteral Stent Symptom Questionnaire (USSQ) Pain Survey. Possible scores range from 0-10, where lower scores indicate better outcome.
Change in pain scores as measured by PROMIS questionnaire
Associated pain burden will be measured using standardized Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity and Interference questionnaire. Possible scores range from 0-10, where lower scores indicate better outcome.
Change in pain scores as measured by Likert Scale Questionnaire
Associated pain burden will be measured using standardized Likert Scale Questionnaire. Possible scores range from 0-10, where lower scores indicate better outcome. For those patients in the SPIRIX arm, they will be asked to complete the Likert Scale Questionnaire approximately 30 minutes after taking each SPIRIX dose.
Number of unplanned clinical encounters
number of clinical encounters (i.e. telephone calls, MyChart messages, emergency room visits, hospital readmissions) related to ureter stent discomfort will be counted.
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University of Texas Southwestern Medical Center
Lead sponsor
assertio Therapeutics, Inc
Collaborator
