Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of Drotaverine hydrochroride in children with recurrent abdominal pain.

DESIGN:

Double blind, randomized placebo-controlled trial.

SETTING:

Pediatric Gastroenterology clinic of a teaching hospital.

PARTICIPANTS:

132 children (age 4-12 y) with recurrent abdominal pain (Apley Criteria) randomized to receivedrotaverine (n=66) or placebo (n=66) orally.

INTERVENTION:

Children between 4-6 years of age received 10 mL syrup orally (20 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks while children >6 years of age received one tablet orally (40 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks.

OUTCOME MEASURES:

Primary: Number of episodes of pain during 4 weeks of use of drug/placebo and number of pain-free days. Secondary: Number of school days missed during the study period, parental satisfaction (on a Likert scale), and occurrence of solicited adverse effects.

RESULTS:

Reduction in number of episodes of abdominal pain [mean (SD) number of episodes 10.3 (14) vs 21.6 (32.4); P=0.01] and lesser school absence [mean (SD) number of school days missed 0.25 (0.85) vs 0.71 (1.59); P=0.05] was noticed in children receiving drotaverine in comparison to those who received placebo. The number of pain-free days, were comparable in two groups [17.4 (8.2) vs 15.6 (8.7); P=0.23]. Significant improvement in parental satisfaction score was noticed on Likert scale by estimation of mood, activity, alertness, comfort and fluid intake. Frequency of adverse events during follow-up period was comparable between children receiving drotaverine or placebo (46.9% vs 46.7%; P=0.98).

CONCLUSION:

Drotaverine hydrochloride is an effective and safe pharmaceutical agent in the management of recurrent abdominal pain in children.

• Authors: Manish Narang, Dheeraj Shah, Hina Akhtar
• Journal: Indian pediatrics (Indian Pediatr) Vol. 52 Issue 10 Pg. 847-51 (Oct 2015) ISSN: 0974-7559 [Electronic] India
• PMID: 26499007 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• drotaverin
• Papaverine

Topics

• Abdominal Pain (drug therapy)
• Absenteeism
• Administration, Oral
• Child
• Child, Preschool
• Chronic Pain (drug therapy)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Gastrointestinal Diseases (drug therapy)
• Humans
• India
• Male
• Papaverine (analogs & derivatives, therapeutic use)
• Treatment Outcome