IDDF2018-ABS-0004 Efficacy and safety of fixed dose combination of drotaverine hydrochloride (80 mg) and paracetamol (500 mg) alone in amelioration of abdominal pain in patients with acute infectious gastroenteritis: a randomised controlled trial

Abstract

Background Comparison of mean pain intensity difference (PID), total pain relief at 2 hours (TOTPAR2), onset of pain relief, decrease in number of pain episodes, global improvement and adverse effects in participants receiving either fixed dose combination of Drotaverine hydrochloride and Paracetamol or Paracetamol alone. Methods A randomised double-blind controlled trial for adults between 18–59 years of age conducted at an Indian tertiary care hospital. Participants of either gender with acute infectious diarrhoea (defined as at least 3 – unformed, watery or soft), stools accompanied by symptoms within 24 hours preceding randomization with duration of illness. Results 252 (126 in each group) participants were enrolled, and all of them received at least one dose of medication. 242 participants completed the study. Mean pain intensity difference (mPID) at 60 min after administration of study medication (mPID60 min) as assessed by VAS, Pain Intensity at all-time points/Total pain relief (TOTPAR), the summed, time-weighted pain relief at 2 hours using both VAS and VRS showed statistically significant improvement in Drotaverine hydrochloride (80 mg) and Paracetamol (500 mg) group. The onset of pain relief was also significantly better in Drotaverine hydrochloride (80 mg) and Paracetamol (500 mg) group when assessed by using VRS. Conclusions Overall, based on the results of this study, it can be concluded that fixed dose combination of Drotaverine hydrochloride (80 mg) and Paracetamol (500 mg) is an effective and safe antispasmodic agent in abdominal pain patients with acute infectious gastroenteritis with a good safety profile. It seems to be a useful addition to the presently available formulations for abdominal pain accompanying acute gastroenteritis.