Manish Narang1, Dheeraj Shah, Hina Akhtar. 1. 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.
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 toreceivedrotaverine (n=66) or placebo (n=66) orally. INTERVENTION: Children between 4-6 years of age received10 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.
RCT Entities:
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: Alice E Martin; Tamsin V Newlove-Delgado; Rebecca A Abbott; Alison Bethel; Joanna Thompson-Coon; Rebecca Whear; Stuart Logan Journal: Cochrane Database Syst Rev Date: 2017-03-06
Authors: Piotr Eder; Piotr Kowalski; Agnieszka Mastalerz-Migas; Barbara Skrzydlo-Radomanska; Wojciech Cichy; Katarzyna Proga Journal: J Clin Med Date: 2022-06-01 Impact factor: 4.964
Authors: Maria Luísa Cordeiro Santos; Ronaldo Teixeira da Silva Júnior; Breno Bittencourt de Brito; Filipe Antônio França da Silva; Hanna Santos Marques; Vinícius Lima de Souza Gonçalves; Talita Costa Dos Santos; Carolina Ladeia Cirne; Natália Oliveira E Silva; Márcio Vasconcelos Oliveira; Fabrício Freire de Melo Journal: World J Clin Pediatr Date: 2022-03-09