Triage Administration of Ondansetron for Gastroenteritis in Children

Gastroenteritis Clinical Trial

Official title:

Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03052361
• Other study ID #: Ondansetron at triage
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 15, 2017
• Est. completion date: October 3, 2020

Study information

• Verified date: October 2020
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: October 3, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Gastroenteritis

Intervention

Drug:
• Ondansetron
Patients allocated to this arm will receive ondansetron in the ED triage.
• Placebos
similar looking and tasting liquid placebo

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

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