Efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80mg) and paracetamol (500mg) in amelioration of abdominal pain in acute infectious gastroenteritis: A randomized controlled trial.

Abstract

This randomized controlled trial was undertaken to assess efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80mg) and paracetamol (PCM) (500mg). This was performed by comparison of mean pain intensity difference, total pain relief at 2h, onset of pain relief, decrease in number of pain episodes, global improvement, and adverse effects. A randomized double-blind controlled trial for adults between 18 and 59years of either gender with acute infectious diarrhea (≥3 unformed, watery, or soft stools with symptoms at least within the last 24h preceding randomization with duration of illness not more than 72h) with moderate-to-severe abdominal pain. Participants were treated with either a fixed-dose combination of oral drotaverine hydrochloride (80mg) and PCM (500mg) or oral PCM (500mg) three times a day for 3days. Of 252 (126 in each group) participants, all received at least one dose of medication. Two hundred forty-two completed the study. Mean pain intensity difference at 60min after administration of study medication by Visual Analogue Scale (VAS) and total pain relief at 2h using both VAS and Verbal Rating Scale showed statistically significant improvement in drotaverine hydrochloride (80mg) and PCM (500mg) group. The onset of pain relief was also significantly better in drotaverine hydrochloride (80mg) and PCM (500mg) group when using VAS. Fixed-dose combination of drotaverine hydrochloride (80mg) and PCM (500mg) is an effective and safe antispasmodic agent in abdominal pain associated with acute infectious gastroenteritis.