Double-blind, placebo-controlled, randomized clinical trial of sublingual or intramuscular piroxicam in the treatment of renal colic - A comparative study

Aims: To investigate the therapeutic effect of the fast-dissolving dosage form (FDDF) of sublingual piroxicam on renal colic compared with the intramuscular (IM) injection form of the same agent in a randomized, double-blind, placebocontrolled clinical trial. Methods: 80 patients were assigned to one of two treatment groups: Group 1 received 40 mg piroxicam FDDF sublingual tablets and IM injection of 2 ml distilled water. Group 2 received an IM injection of 40 mg piroxicam and two sublingual tablets of placebo. At baseline and 30 min after the medication, vital signs were recorded and the pain intensity was evaluated by the patient using a numeric rating scale. Results: The overall efficacy of the treatment was 90%. There was no significant difference with respect to the required rescue treatment (p = 0.328), pain relapse within 24 h (p = 0.434) and the decrease in vital signs and numeric rating scale in both groups (p > 0.05). Conclusion: The piroxicam FDDF tablet was found to be as effective as the IM injection form of the same agent in the treatment of renal colic. The FDDF is a good alternative to the parenteral form because of its earlier onset of action and ease of self- administration which increases patient compliance.