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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. 2020 May 27; 21(1):435.T

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.

Authors+Show Affiliations

Sections 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 Calgary, Calgary, AB, Canada. Stephen.freedman@ahs.ca.Alberta Children's Hospital, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.The Hospital for Sick Children, Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. Department of Statistical Science, University College London, London, UK.The Hospital for Sick Children, Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, ON, Canada.Institute of Health Economics, Edmonton, AB, Canada.Departments of Pediatric Emergency Medicine and Pediatrics, CHU Sainte-Justine, Université de Montréal, Montreal, QC, Canada.Children's Hospital of Eastern Ontario, Departments of Pediatric and Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Women and Children's Health Research Institute, Edmonton, AB, Canada.Max Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.Division of Paediatric Emergency Medicine, Department of Paediatrics, Children's Hospital LHSC, Western University, London, ON, Canada.Institute of Health Economics and the Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.Divisions of Emergency Medicine and Clinical Pharmacology and Toxicology, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.Max Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

32460879

Citation

Freedman, Stephen B., et al. "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, vol. 21, no. 1, 2020, p. 435.
Freedman SB, Williamson-Urquhart S, Heath A, et al. 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. 2020;21(1):435.
Freedman, S. B., Williamson-Urquhart, S., Heath, A., Pechlivanoglou, P., Hopkin, G., Gouin, S., Plint, A. C., Dixon, A., Beer, D., Joubert, G., McCabe, C., Finkelstein, Y., & Klassen, T. P. (2020). 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, 21(1), 435. https://doi.org/10.1186/s13063-020-04347-6
Freedman SB, et al. 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. 2020 May 27;21(1):435. PubMed PMID: 32460879.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Freedman,Stephen B, AU - Williamson-Urquhart,Sarah, AU - Heath,Anna, AU - Pechlivanoglou,Petros, AU - Hopkin,Gareth, AU - Gouin,Serge, AU - Plint,Amy C, AU - Dixon,Andrew, AU - Beer,Darcy, AU - Joubert,Gary, AU - McCabe,Christopher, AU - Finkelstein,Yaron, AU - Klassen,Terry P, AU - ,, Y1 - 2020/05/27/ PY - 2020/03/09/received PY - 2020/04/24/accepted PY - 2020/5/29/entrez PY - 2020/5/29/pubmed PY - 2020/5/29/medline KW - Child KW - Dehydration KW - Emergency service, hospital KW - Gastroenteritis KW - Ondansetron KW - Randomized controlled trial KW - Vomiting SP - 435 EP - 435 JF - Trials JO - Trials VL - 21 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/32460879/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04347-6 DB - PRIME DP - Unbound Medicine ER -