GastroenteritisPhase 2/3NCT03052361
Triage Administration of Ondansetron for Gastroenteritis in Children
A Phase 2/3 study testing Ondansetron in people with Gastroenteritis, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The investigators aim to assess whether ondansetron given at triage can reduce the number of patients requiring emergency department observation in children with acute gastroenteritis. The investigators will also assess the improvement of patient comfort and total length of stay Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Ondansetron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2017to 3 Oct 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged more than 6 months and weight ≥ 8kg
- 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.
Who cannot join
- Severe dehydration (based on poor capillary refill or hypotension)
- 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
Show all 10Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial
The investigators aim to assess whether ondansetron given at triage can reduce the number of patients requiring emergency department observation in children with acute gastroenteritis. The investigators will also assess the improvement of patient comfort and total length of stay
Read the detailed description
Background:
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
- Gastroenteritis
- Being tested
- Ondansetron, Placebos
- Keywords
- Children, emergency department, ondansetron
- Medical subject headings
- Gastroenteritis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
Patients allocated to this arm will receive ondansetron in the ED triage.
PlacebosDrug
similar looking and tasting liquid placebo
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | 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 Receives: Drug: Ondansetron |
| control | Placebo comparator | Patients allocated to this arm will receive an identical looking/tasting placebo in the ED triage. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposition
The number of patients that are discharged immediately after initial medical assessment
Measured: 12 hours
Secondary outcomes (8)
Length of Stay
The ED length of stay from registration to discharged
Measured: 12 hours
ED vomiting
The number of episodes of vomiting in the ED.
Measured: 12 hours
48 hours vomiting
The number of episodes of vomiting in the 24 and 48 hours
Measured: 48 hours
Return visit
The number of patients who return to ED and to a physician within 48 hours.
Measured: 48 hours
Nausea level
Improvement of patient comfort evaluated by parents according to a Baxter Animated Retching Face Scale (BARF) scale
Measured: 12 hours
Alternative diagnosis
In a safety analysis, the investigator will evaluate if the nurse at triage was correct in suspecting that the enrolled children were suffering from gastroenteritis and we will compare the proportion of alternate diagnosis in both groups
Measured: 12 hours
Left without being sen
The investigator will compare the proportion of children who left the ED without being seen by a physician.
Measured: 12 hours
Rescue medication
The proportion of children requiring a rescue medication for persistent nausea/vomiting
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start15 Jul 2017
- Primary completion3 Sep 2020
- Study completion3 Oct 2020
Why it stopped: The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Gravel, St. Justine's Hospital
- Investigators
- Jocelyn Gravel, MD, Principal investigator, Sainte-Justine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052361
- Sponsor's protocol ID
- Ondansetron at triage
- Status last verified
- Oct 2020
- First submitted
- 7 Feb 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weill O, Lucas N, Bailey B, Marquis C, Gravel J. Triage Administration of Ondansetron for Gastroenteritis in Children: A Randomized Controlled Trial. Pediatr Emerg Care. 2026 Sep 24. doi: 10.1097/PEC.0000000000003715. Online ahead of print.
PubMed 42782131
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03052361
- Acronym / sponsor ID
- Ondansetron at triage
- Conditions
- Gastroenteritis
- Keywords
- Children, emergency department, ondansetron
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Oct 2020 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to assess whether ondansetron given at triage can reduce the number of patients requiring emergency department observation in children with acute gastroenteritis. The investigators will also assess the improvement of patient comfort and total length of stay
Detailed description
Background:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: OndansetronPatients 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 |
| control | Placebo comparator | Drug: PlacebosPatients allocated to this arm will receive an identical looking/tasting placebo in the ED triage. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged more than 6 months and weight ≥ 8kg
- 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.
Key exclusion criteria (10 listed)
- Severe dehydration (based on poor capillary refill or hypotension)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronAlso: ZofranPatients allocated to this arm will receive ondansetron in the ED triage. | Drug | Ondansetron |
| Placebossimilar looking and tasting liquid placebo | Drug | control |
Primary outcome
Disposition
Time frame: 12 hours
The number of patients that are discharged immediately after initial medical assessment
8 secondary outcomes
Length of Stay
Time frame: 12 hours
ED vomiting
Time frame: 12 hours
48 hours vomiting
Time frame: 48 hours
Return visit
Time frame: 48 hours
Nausea level
Time frame: 12 hours
Alternative diagnosis
Time frame: 12 hours
Left without being sen
Time frame: 12 hours
Rescue medication
Time frame: 12 hours
Results and safety
The study was stopped early (reason given: The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 42782131Weill O, Lucas N, Bailey B, Marquis C, Gravel J. Triage Administration of Ondansetron for Gastroenteritis in Children: A Randomized Controlled Trial. Pediatr Emerg Care. 2026 Sep 24. doi: 10.1097/PEC.0000000000003715. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn Gravel, MD principal investigator
Sainte-Justine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ondansetron in people with Gastroenteritis, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disposition (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.