Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial
Abstract Background There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency depart...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-05-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04347-6 |
| _version_ | 1818257763007987712 |
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| author | Stephen B. Freedman Sarah Williamson-Urquhart Anna Heath Petros Pechlivanoglou Gareth Hopkin Serge Gouin Amy C. Plint Andrew Dixon Darcy Beer Gary Joubert Christopher McCabe Yaron Finkelstein Terry P. Klassen on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group |
| author_facet | Stephen B. Freedman Sarah Williamson-Urquhart Anna Heath Petros Pechlivanoglou Gareth Hopkin Serge Gouin Amy C. Plint Andrew Dixon Darcy Beer Gary Joubert Christopher McCabe Yaron Finkelstein Terry P. Klassen on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group |
| author_sort | Stephen B. Freedman |
| collection | DOAJ |
| description | Abstract Background There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice. Methods/design DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial. Discussion Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes. Trial Registration ClinicalTrials.gov : NCT03851835 . Registered on 22 February 2019. |
| first_indexed | 2024-12-12T17:48:49Z |
| format | Article |
| id | doaj.art-26b6dddcbef24072b00551ec61da0819 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T17:48:49Z |
| publishDate | 2020-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-26b6dddcbef24072b00551ec61da08192022-12-22T00:16:52ZengBMCTrials1745-62152020-05-0121111310.1186/s13063-020-04347-6Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trialStephen B. Freedman0Sarah Williamson-Urquhart1Anna Heath2Petros Pechlivanoglou3Gareth Hopkin4Serge Gouin5Amy C. Plint6Andrew Dixon7Darcy Beer8Gary Joubert9Christopher McCabe10Yaron Finkelstein11Terry P. Klassen12on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study GroupSections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Alberta Children’s Hospital, Alberta Children’s Hospital Research Institute, Cumming School of Medicine, University of CalgaryAlberta Children’s Hospital, Cumming School of Medicine, University of CalgaryThe Hospital for Sick Children, Division of Biostatistics, Dalla Lana School of Public Health, University of TorontoThe Hospital for Sick Children, Institute for Health Policy Management and Evaluation, University of TorontoInstitute of Health EconomicsDepartments of Pediatric Emergency Medicine and Pediatrics, CHU Sainte-Justine, Université de MontréalChildren’s Hospital of Eastern Ontario, Departments of Pediatric and Emergency Medicine, University of OttawaStollery Children’s Hospital, Department of Pediatrics, University of Alberta, Women and Children’s Health Research InstituteMax Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children’s Hospital Research Institute of ManitobaDivision of Paediatric Emergency Medicine, Department of Paediatrics, Children’s Hospital LHSC, Western UniversityInstitute of Health Economics and the Department of Emergency Medicine, University of AlbertaDivisions of Emergency Medicine and Clinical Pharmacology and Toxicology, Department of Paediatrics, Hospital for Sick Children, University of TorontoMax Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children’s Hospital Research Institute of ManitobaAbstract Background There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice. Methods/design DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial. Discussion Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes. Trial Registration ClinicalTrials.gov : NCT03851835 . Registered on 22 February 2019.http://link.springer.com/article/10.1186/s13063-020-04347-6OndansetronChildVomitingGastroenteritisDehydrationEmergency service, hospital |
| spellingShingle | Stephen B. Freedman Sarah Williamson-Urquhart Anna Heath Petros Pechlivanoglou Gareth Hopkin Serge Gouin Amy C. Plint Andrew Dixon Darcy Beer Gary Joubert Christopher McCabe Yaron Finkelstein Terry P. Klassen on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial Trials Ondansetron Child Vomiting Gastroenteritis Dehydration Emergency service, hospital |
| title | Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial |
| title_full | Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial |
| title_fullStr | Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial |
| title_full_unstemmed | Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial |
| title_short | Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial |
| title_sort | multi dose oral ondansetron for pediatric gastroenteritis study protocol for the multi dose oral ondansetron for pediatric acute gastroenteritis dose age pragmatic randomized controlled trial |
| topic | Ondansetron Child Vomiting Gastroenteritis Dehydration Emergency service, hospital |
| url | http://link.springer.com/article/10.1186/s13063-020-04347-6 |
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