Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial.
| dc.contributor.author | Narang, Manish | |
| dc.contributor.author | Shah, Dheeraj | |
| dc.contributor.author | Akhtar, Hina | |
| dc.date.accessioned | 2016-02-08T11:12:47Z | |
| dc.date.available | 2016-02-08T11:12:47Z | |
| dc.date.issued | 2015-10 | |
| dc.description.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. | en_US |
| dc.identifier.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. | en_US |
| dc.identifier.uri | https://imsear.searo.who.int/handle/123456789/172115 | |
| dc.language.iso | en | en_US |
| dc.source.uri | https://www.indianpediatrics.net/oct2015/oct-847-851.htm | en_US |
| dc.subject | Abdominal pain | en_US |
| dc.subject | Parental satisfaction | en_US |
| dc.subject | Treatment | en_US |
| dc.title | Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial. | en_US |
| dc.type | Article | en_US |