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

Abstract

BACKGROUND AND AIM:

This randomized controlled trial was undertaken to assess efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80 mg) and paracetamol (PCM) (500 mg). This was performed by comparison of mean pain intensity difference, total pain relief at 2 h, onset of pain relief, decrease in number of pain episodes, global improvement, and adverse effects.

METHODS:

A randomized double-blind controlled trial for adults between 18 and 59 years of either gender with acute infectious diarrhea (≥ 3 unformed, watery, or soft stools with symptoms at least within the last 24 h preceding randomization with duration of illness not more than 72 h) with moderate-to-severe abdominal pain. Participants were treated with either a fixed-dose combination of oral drotaverine hydrochloride (80 mg) and PCM (500 mg) or oral PCM (500 mg) three times a day for 3 days.

RESULTS:

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 60 min after administration of study medication by Visual Analogue Scale (VAS) and total pain relief at 2 h using both VAS and Verbal Rating Scale showed statistically significant improvement in drotaverine hydrochloride (80 mg) and PCM (500 mg) group. The onset of pain relief was also significantly better in drotaverine hydrochloride (80 mg) and PCM (500 mg) group when using VAS.

CONCLUSION:

Fixed-dose combination of drotaverine hydrochloride (80 mg) and PCM (500 mg) is an effective and safe antispasmodic agent in abdominal pain associated with acute infectious gastroenteritis.

• Authors: Shiva Narang, Jitender Koli
• Journal: Journal of gastroenterology and hepatology (J Gastroenterol Hepatol) Vol. 33 Issue 12 Pg. 1942-1947 (Dec 2018) ISSN: 1440-1746 [Electronic] Australia
• PMID: 29968385 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Chemical References

• Analgesics
• Drug Combinations
• Tablets
• drotaverine hydrochloride-paracetamol drug combination
• Acetaminophen
• Papaverine

Topics

• Abdominal Pain (diagnosis, drug therapy, etiology)
• Acetaminophen (administration & dosage, adverse effects)
• Acute Pain (diagnosis, drug therapy, etiology)
• Administration, Oral
• Adolescent
• Adult
• Analgesics (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Combinations
• Dysentery (complications, diagnosis, drug therapy)
• Female
• Humans
• India
• Male
• Middle Aged
• Pain Measurement
• Papaverine (administration & dosage, adverse effects, analogs & derivatives)
• Tablets
• Time Factors
• Treatment Outcome
• Young Adult