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.


METHODS
Double blind, randomized placebo-controlled trial.


METHODS
Pediatric Gastroenterology clinic of a teaching hospital.


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


METHODS
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.


METHODS
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).


CONCLUSIONS
Drotaverine hydrochloride is an effective and safe pharmaceutical agent in the management of recurrent abdominal pain in children.
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, University College of Medical Sciences (University of Delhi) and Guru Teg Bahadur Hospital, Delhi, India. Correspondence to: Dr Dheeraj Shah, Associate Professor, Department of Pediatrics, UCMS and GTB Hospital, Dilshad Garden, Delhi 110 095, India. shahdheeraj@hotmail.com.
Manish
M
Narang
Dheeraj
D
Shah
Hina
H
Akhtar
D015746:Abdominal Pain / Q000188:drug therapy*; D000041:Absenteeism; D000284:Administration, Oral; D002648:Child; D002675:Child, Preschool; D059350:Chronic Pain / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D006801:Humans; D007194:India; D008297:Male; D010208:Papaverine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
C005317:drotaverin; D010208:Papaverine