Piroxicam and paracetamol in the prevention of early recurrent pain and emergency department readmission after renal colic: Randomized placebo-controlled trial.

Objective: Renal colic (RC) is a common urologic emergency often leading to significant pain and recurrent hospital visits. This study aimed to compare the efficacy and safety of piroxicam versus paracetamol in preventing pain recurrence and hospital readmission in patients treated for RC and discharged from the emergency department (ED).

Methods: A prospective, randomized, single-blind trial was conducted in four EDs. Eligible adults with RC were randomized to receive oral piroxicam, paracetamol, or placebo for 5 days post-ED discharge. Primary outcomes included pain recurrence and ED readmission within 7 days. Secondary outcomes included time to recurrence and treatment-related side effects.

Results: Of 1383 enrolled patients, no significant differences were observed among the groups regarding baseline characteristics. Pain recurrence rates within 7 days were 29% (95% confidence interval [CI] 24.9%-33.2%) for piroxicam, 30.3% (95% CI 26.1%-34.5%) for paracetamol, and 30.8% (95% CI 26.6%-35.0%) for placebo, with no significant between-group differences (p = 0.84). Among patients experiencing recurrence, the majority encounter it within the initial 2 days following their discharge (86% in the piroxicam group, 84.1% in the paracetamol group, and 86% in the placebo group, respectively). ED readmission rates were similar across groups: 20.8% (95% CI 17.1%-24.5%) in the piroxicam group, 23.8% (95% CI 19.9%-27.7%) in the paracetamol group, and 22.9% (95% CI 19.1%-26.8%) in the placebo group (p = 0.52). The piroxicam group reported significantly higher adverse effects compared to others.

Conclusions: Piroxicam and paracetamol did not demonstrate efficacy in preventing pain recurrence or ED readmission within the first week following RC treatment.