Triage Administration of Ondansetron for Gastroenteritis in Children

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

Study Overview

• Status: Terminated
• Conditions: Gastroenteritis
• Intervention / Treatment: Drug: Ondansetron; Drug: Placebos

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: Ondansetron; Patients allocated to this arm will receive ondansetron in the ED triage.; Other Names: Zofran
PLACEBO_COMPARATOR: control; Patients allocated to this arm will receive an identical looking/tasting placebo in the ED triage.	Drug: Placebos; similar looking and tasting liquid placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disposition	The number of patients that are discharged immediately after initial medical assessment	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	The ED length of stay from registration to discharged	12 hours
ED vomiting	The number of episodes of vomiting in the ED.	12 hours
48 hours vomiting	The number of episodes of vomiting in the 24 and 48 hours	48 hours
Return visit	The number of patients who return to ED and to a physician within 48 hours.	48 hours
Nausea level	Improvement of patient comfort evaluated by parents according to a Baxter Animated Retching Face Scale (BARF) scale	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	12 hours
Left without being sen	The investigator will compare the proportion of children who left the ED without being seen by a physician.	12 hours
Rescue medication	The proportion of children requiring a rescue medication for persistent nausea/vomiting	12 hours

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2017
• Primary Completion (ACTUAL): September 3, 2020
• Study Completion (ACTUAL): October 3, 2020

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (ACTUAL): February 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Children; emergency department; ondansetron
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: Ondansetron at triage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No