Randomized controlled trial of NSAID prior to cystoscopic ureteral stent removal in a pediatric population

Ureteral spasm, common with ureteral stents, is partially mediated by prostaglandins and may be suppressed by cyclooxygenase inhibitors like non-steroidal anti-inflammatory (NSAIDs). Practices currently vary widely for pain management in patients with ureteral stents, sometimes including opioids. We aimed to determine if NSAID given prior to stent removal would reduce postoperative pain. We hypothesized there would be at least a 75% reduction in postoperative severe pain (pain score ≥7) in patients receiving ibuprofen compared to placebo. We performed a double-blind, placebo-controlled randomized controlled trial on pediatric urology patients with an indwelling ureteral stent undergoing removal in the operating room from 2014 to 2019. 20 patients in each arm were needed to achieve 80% power to detect a 75% reduction in the estimated 55% incidence of severe postoperative pain (α = 0.05). Patients ≥4 years old who had a unilateral stent placed after treatment of urolithiasis or ureteropelvic junction obstruction were randomized to NSAID or placebo in a 1:1 ratio at least 15 min prior to scheduled stent removal. Patients estimated pain using Faces Pain Scale-Revised (FPS-R) or visual analogue scale (VAS) prior to and 24 h after stent removal. 254 patients undergoing stent removal were assessed for eligibility, and 44 randomized patients were analyzed using intention to treat analysis. The cohorts were demographically similar and received similar anesthesia treatment. There was no significant difference in maximum post anesthesia care unit pain score (p = 0.269) or use of in-hospital opioids (p = 0.626) between the two groups. No difference was seen in the incidence of severe postoperative pain (p = 1.0), thus rejecting the hypothesis. Significant worsened postoperative pain (pain score increases of ≥2 between time points) decreased from 22.7% to 13.6% between placebo and NSAID, but this did not reach significance (p = 0.410). There was no difference in postoperative pain for patients undergoing ureteral stent removal given preoperative NSAID versus placebo. The incidence of severe pain before and after stent removal was low, ranging from 4.5 to 9.1%. Research to understand the etiology of pain after stent removal and techniques to minimize or prevent discomfort should continue in order to optimize patient outcomes.