Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial.
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Date
2015-10
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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.
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Keywords
Abdominal pain, Parental satisfaction, Treatment
Citation
Narang Manish, Shah Dheeraj, Akhtar Hina. Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial. Indian Pediatrics. 2015 Oct; 52(10): 847-851.