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
To evaluate the efficacy and safety of Drotaverine hydrochroride in children with recurrent abdominal pain.
Double blind, randomized placebo-controlled trial.
Pediatric Gastroenterology clinic of a teaching hospital.
132 children (age 4-12 years) with recurrent abdominal pain (Apley Criteria) randomized to receive drotaverine (n=66) or placebo (n=66) orally.
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.
Number of episodes of pain during 4 weeks of use of drug/placebo and number of pain-free days.
Number of school days missed during the study period, parental satisfaction (on a Likert scale), and occurrence of solicited adverse effects.
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).
Drotaverine hydrochloride is an effective and safe pharmaceutical agent in the management of recurrent abdominal pain in children.
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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