Triage Administration of Ondansetron for Gastroenteritis in Children
NCT ID: NCT03052361
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
81 participants
INTERVENTIONAL
2017-07-15
2020-10-03
Brief Summary
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Detailed Description
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Acute gastroenteritis is one the most common cause of emergency room visits. Studies have demonstrated that ondansetron is effective in reducing vomiting in children with gastroenteritis and improve outcomes by decreasing intravenous rehydration and hospital admission of those patients. Giving ondansetron to children with suspected gastroenteritis immediately at triage could reduce the number of patients requiring observation in the emergency department after medical consultation and improve patients' outcomes.
Objective:
The aim of this study is to assess the effectiveness of triage-initiated administration of ondansetron for suspected gastroenteritis in the paediatric emergency department. The investigators aim to assess whether ondansetron given at triage can reduce the number of patients requiring observation in children with acute gastroenteritis. The investigators will also assess the improvement of patient comfort and total length of stay.
Methods:
This will be a randomized controlled trial performed in a tertiary paediatric emergency department. Participants will include all infants more than 8kg who present to the emergency department with at least four vomiting in the previous 24 hours and the last vomiting that occurred in the previous 2h. The intervention will consist of giving ondansetron at triage versus placebo. The primary outcome will be the number of patients requiring observation after medical consultation in both groups. Secondary objectives will be the number of episodes of vomiting after receiving the intervention, length of stay in the emergency department and the proportion of children who will return to a physician within 48 hours. The investigators will assess the improvement of patient comfort evaluated by parents according to a BARF (Baxter Animated Retching Face) Scale within the ondansetron group vs placebo. The primary analysis will be the comparison of the proportion of observation for the two groups. Based on a preliminary study of the currents children suffering from gastro-enteritis, it was estimated that the recruitment of 248 participants will provide a power of 90% to identify a 20% difference in the proportion of observed patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ondansetron
Patients allocated to this arm will receive ondansetron in the ED triage. Posology of ondansetron will be adapted to weight: doses of 2 mg for children weighting between 8 and 15 kg, 4 mg for children weighting between 15 to 30 kg and 8 mg for children heavier than 30 kg
Ondansetron
Patients allocated to this arm will receive ondansetron in the ED triage.
control
Patients allocated to this arm will receive an identical looking/tasting placebo in the ED triage.
Placebos
similar looking and tasting liquid placebo
Interventions
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Ondansetron
Patients allocated to this arm will receive ondansetron in the ED triage.
Placebos
similar looking and tasting liquid placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 4 non-bilious, non-bloody vomiting in the preceding 24 hours
* The last vomiting occured less than 2 hours ago
* No other diagnostic more likely than gastroenteritis suspected by the nurse at triage.
Exclusion Criteria
* Underlying disease that could affect the assessment of hydration (such as renal failure or hypoalbuminemia)
* Bilious or bloody vomiting
* Bloody stool
* A history of abdominal surgery
* Allergy to ondansetron
* Long QT syndrome or major cardiac condition
* Previous enrolment in the study.
* Girl at risk of pregnancy (pubertal girl)
* Inability to obtain parental informed consent (language barrier, absence, etc.)
6 Months
17 Years
ALL
No
Sponsors
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St. Justine's Hospital
OTHER
Responsible Party
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Jocelyn Gravel
Principal investigator
Principal Investigators
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Jocelyn Gravel, MD
Role: PRINCIPAL_INVESTIGATOR
Sainte-Justine Hospital
Locations
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CHU Sainte-Justine
Montreal, Quebec, Canada
Countries
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Other Identifiers
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Ondansetron at triage
Identifier Type: -
Identifier Source: org_study_id
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