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Drotaverine Hydrochloride is effective and safe in Children with Recurrent Abdominal Pain

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

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 years) with recurrent abdominal pain (Apley Criteria) randomized to receive drotaverine (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.

Reference:

MANISH NARANG et al. Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial “Indian Pediatr”[jour] 2015 Oct;52(10).

Available at: http://www.ncbi.nlm.nih.gov/pubmed/26499007/

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