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Randomized Study of Ondansetron Versus Domperidone in the Treatment of Children with Acute Gastroenteritis

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Randomized Study of Ondansetron Versus Domperidone in the Treatment of Children with Acute Gastroenteritis Elmer ress Original Article J Clin Med Res • 2013;5(6):460-466 Randomized Study of Ondansetron Versus Domperidone in the Treatment of Children With Acute Gastroenteritis Sanguansak Rerksuppaphola, c, Lakkana Rerksuppapholb Abstract Introduction Background: Acute gastroenteritis (AGE) is a common condition Acute gastroenteritis (AGE) is a common cause of morbidity among children that is frequently accompanied by vomiting. Symp- and mortality in children. AGE is frequently accompanied tomatic control of vomiting is important as it improves patient’s with vomiting that interferes with a successful oral rehydra- general condition and reduces the need for intravenous therapy and tion therapy (ORT). Successful symptomatic management hospitalization. Antiemetic agents including ondansetron and dom- of vomiting not only provides substantial comfort for the peridone are used to provide symptomatic relief but the existing patient, but enables the child to be fed orally thus poten- studies do not provide enough evidence of better efficacy for one tially reduces the need for intravenous therapy (IVT) and over another. prolonged hospitalization. Several anti-emetic drugs such Methods: Seventy-six Thai children under the age of 15 with AGE as prochlorperazine, promethazine hydrochloride and meto- were randomized to receive either ondansetron or domperidone. clopramide are used for the management of vomiting; how- The primary outcome of the study was the proportion of the patients ever, their efficacy is limited and comes at the cost of some in each group who had no episode of vomiting 24 hours after the side effects [1-4]. Currently, there is no standard guideline start of treatment. for pharmacological treatment of vomiting in children with gastroenteritis. Results: Primary outcome was met in 62% of patients in ondanse- Domperidone is a benzimidazole derivative and a dopa- tron group and 44% of patients in domperidone group (P = 0.16). mine antagonist that acts on the chemoreceptor trigger zone. Patients in domperidone group received more doses of the drug It is widely used for the management of vomiting in children within 24 hours after the start of the treatment compared to ondan- [5], however, the evidence of its efficacy is still not satis- setron group (P = 0.01). No adverse effect was observed in any of the two groups. factory [6]. A Japanese study of domperidone plus ORT vs. ORT alone in children with AGE showed a trend towards a Conclusions: Ondansetron can be considered a safe comparable better control of vomiting within two hours of drug adminis- alternative to commonly-used domperidone in Thai children who tration in domperidone group, but the difference was not sta- suffer from symptoms of gastroenteritis. Larger clinical trials are tistically significant [7]. Van Egan et al however, showed that needed to further explore the effectiveness of the two medications. domperidone suppositories significantly decrease the num- ber of vomiting in children with AGE compared to metoclo- pramide or placebo [8]. Keywords: Ondansetron; Domperidone; Acute gastroenteritis; Ondansetron is a serotonin (subtype 3) antagonist which Child has been approved for treatment of nausea and vomiting induced by chemotherapy or radiotherapy as well as for Manuscript accepted for publication July 9, 2013 post-operative nausea and vomiting. Compared to dopamine antagonists, it has fewer serious side effects such as extra- a Department of Pediatrics, Faculty of Medicine, Srinakharinwirot pyramidal symptoms and demonstrates better efficacy in the University, Nakorn Nayok, Thailand bDepartment of Preventive Medicine, Faculty of Medicine, treatment of vomiting. This leads to the clinical use of on- Srinakharinwirot University, Nakorn Nayok, Thailand dansetron off label especially for children’s vomiting caused cCorresponding author: Sanguansak Rerksuppaphol, Department by AGE [9-11]. Systematic reviews and meta-analyses of the of Pediatrics, Faculty of Medicine, Srinakharinwirot University, 62 subject concluded that there are few studies on the role of Mo 7, Rangsit-Nakorn Nayok Rd., NakornNayok, Thailand. ondansetron in the treatment of vomiting in children. While Email: [email protected] the evidence is not enough to be conclusive, a trend towards doi: http://dx.doi.org/10.4021/jocmr1500w positive efficacy is seen [6, 12, 13] However, there are dif- 460 Articles © The authors | Journal compilation © J Clin Med Res and Elmer Press™ | www.jocmr.org 461 This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited Rerksuppaphol et al J Clin Med Res • 2013;5(6):460-466 ferences in methodology of studies included in these reviews tory of allergy to any anti-emetic medication, or 6) could not such as route of administration for medication (orally vs. in- tolerate oral feeding were excluded from the study. travenously) [6]. For example, in a study by Ramsook et al [10] showed that oral ondansetron reduces the episodes of Intervention vomiting, the need for IVT, and hospitalization. Similar re- sults were observed by Freedman et al [9] in children treated Participants were randomized to receive ondansetron or with a single oral dose of ondansetron in the emergency de- domperidone. Randomization was done using a computer- partment. Overall, there is not enough evidence to support ized program with blocks of 2 by a statistician who was not the routine use of oral ondansetron in these patients and fur- involved in the conduct of the study. Children were given ther studies are needed [14]. the study treatments at the out-patient clinic. If a child had Our group has previously reported the efficacy of intra- an immediate episode of vomiting following the admin- venous ondansetron for the treatment of vomiting in children istration of the medication, a second dose of the assigned admitted to hospital [15]. This study will further explore anti-emetic would be administered. Thirty minutes after the role of oral ondansetron in an outpatient setting. More the administration of anti-emetic, children were allowed to specifically, this study aims to determine the efficacy of oral take any other food. Patients were observed at the pediatric ondansetron compared to domperidone for the treatment of outpatient department for one hour after taking the assigned vomiting in children who presented with AGE at the out- anti-emetic. Those who had no ongoing vomiting were sent patient department of Srinakharinwirot University Hospital home with the assigned anti-emetic and oral dehydration so- in Thailand. lution (ORS) powder. If the patient still had ongoing vomit- The study is registered into the Thai Clinical Trials Reg- ing, he/she was re-assessed and was given another dose of istry with the following trial number: TCTR20120000011. the assigned anti-emetic. Children with severe vomiting who could not take any food orally were categorized as treatment failure and were admitted to in-patient unit for proper man- Methods agement (in which case they were taken out of the study). Children who were treated at home were advised to take the The study was an open-label randomized controlled trial to assigned anti-emetic at the same dose when they had nausea compare the efficacy of oral disintegrating ondansetron tab- or ongoing vomiting (PRN; as needed) but only in intervals let with domperidone suspension in preventing vomiting in greater than 8 hours. children with AGE. The study was conducted in the pediat- ric out-patient department (OPD) of Srinakharinwirot Uni- Ondansetron group versity Hospital, Thailand between August and December, 2012. The protocol was approved by the Ethic Committee of Children received orally disintegrating ondansetron tablet the Faculty of Medicine, Srinakharinwirot University. Writ- (Zofran ZydisTM; GlaxoSmithKline, London, UK) based on ten informed consent and assent were obtained from parents their body weight. The prescribed dose was 2 mg for chil- or legal guardians and children, respectively. Children could dren weighing less than 15 kg, 4 mg for children weighing withdraw from the study at any point during the study. 15 - 30 kg, and 8 mg for children weighing more than 30 kg. Population Domperidone group Children 15 years of age or younger presenting to the clinic Children received domperidone suspension (Moridon®; with symptoms consistent with AGE were further assessed New Life Pharma, Bangkok, Thailand) based on their body for eligibility to participate in the study. The inclusion cri- weight. The prescribed dose was 2.5 mg for children weigh- teria included: 1) three or more non-bilious, non-bloody ing less than 15 kg, 5 mg for children weighing 15 - 30 kg vomiting episodes within 24 hours prior to their attendance and 10 mg for children weighing more than 30 kg. at clinic, and 2) other signs and symptoms consistent with All medications were directly purchased from the manu- AGE such as diarrhea, abdominal pain, bloating or discom- facturing companies. The companies had no role in the con- fort, low grade fever, etc. ception, design or conduct of the study or in any processes Patients who: 1) used any anti-emetic medication within related to the study in any way. 4 hours prior to the signing of the informed consent form, 2) had underlying diseases such as liver disease, renal disease, Data collection and monitoring congenital heart disease, neurological disease, malignancy, immune
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