Abstract

Introduction: In this trial, we aimed to asses the therapeutic effect of sublingual piroxicam fast-dissolving dosage form (FDDF) on acute renal colic as an alternative therapy to the parenteral options, compared with the intramuscular (IM) injection form of the same agent in a randomized, double-blind placebo controlled clinical trial.

Materials and Methods: Eighty patients of acute renal colic were randomly assigned into two groups; group 1 received 40 mg piroxicam FDDF sublingual tablets and IM injection of 2 ml isotonic NaCl, and group 2 received an IM injection of 40 mg piroxicam and two sublingual tablets of placebo. For each patient just before and 30 minutes after the administration of the study drugs, pain intensity was evaluated by using Numeric Rating Scale (NRS) and Renal Colic Symptom Score (RCSS). After 30 minutes, the success of treatment was defined as a decrease at least 50% in NRS and RCSS. Additionally each patient was asked for the pain relapse within the 24 hours of medication. Chi-square and t-tests were used for statistical analysis.

Results: The rate of overall efficacy of the treatment was 90%. Five patients (12.8%) in the piroxicam FDDF tablet group and 3 patients (7.3%) in the piroxicam IM group required rescue treatment (p=0.328). Pain relapse was seen on 7 patients (17.9%) in the tablet group and 9 patients (22%) in IM injection group within the 24 hours of medication (p=0.434). No significant difference was found in decreasing vital signs, NRS and RCSS for each group (p>0.05). No side effects were reported with use of either treatment.

Conclusion: Piroxicam FDDF tablet is as effective as IM injection form of the same agent in the treatment of acute renal colic. Fast-dissolving dosage form is a good alternative to the parenteral form because of its earlier onset of action and ease of self administration which increases the patient compliance.