Triage Administration of Ondansetron for Gastroenteritis in Children

NCT03052361 | Terminated Phase 2

• 1 other identifier: Ondansetron at triage
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gastroenteritis

Keywords

Children; emergency department; ondansetron

Outcome Measures

Primary Outcomes (1)

• Disposition

  The number of patients that are discharged immediately after initial medical assessment

  12 hours

Secondary Outcomes (8)

• Length of Stay

  12 hours

• ED vomiting

  12 hours

• 48 hours vomiting

  48 hours

• Return visit

  48 hours

• Nausea level

  12 hours

Study Arms (2)

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

Drug: Ondansetron

control

PLACEBO COMPARATOR

Patients allocated to this arm will receive an identical looking/tasting placebo in the ED triage.

Drug: Placebos

Interventions

Ondansetron DRUG

Patients allocated to this arm will receive ondansetron in the ED triage.

Also known as: Zofran

Ondansetron

Placebos DRUG

similar looking and tasting liquid placebo

control

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Gastroenteritis; Emergencies

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Jocelyn Gravel, MD

  Sainte-Justine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: July 15, 2017
• Primary Completion: September 3, 2020
• Study Completion: October 3, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)