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Triage Administration of Ondansetron for Gastroenteritis in Children

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ClinicalTrials.gov Identifier: NCT03052361
Recruitment Status : Terminated (The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.)
First Posted : February 14, 2017
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital

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

Condition or disease Intervention/treatment Phase
Gastroenteritis Drug: Ondansetron Drug: Placebos Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial
Actual Study Start Date : July 15, 2017
Actual Primary Completion Date : September 3, 2020
Actual Study Completion Date : October 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

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 Name: 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




Primary Outcome Measures :
  1. Disposition [ Time Frame: 12 hours ]
    The number of patients that are discharged immediately after initial medical assessment


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: 12 hours ]
    The ED length of stay from registration to discharged

  2. ED vomiting [ Time Frame: 12 hours ]
    The number of episodes of vomiting in the ED.

  3. 48 hours vomiting [ Time Frame: 48 hours ]
    The number of episodes of vomiting in the 24 and 48 hours

  4. Return visit [ Time Frame: 48 hours ]
    The number of patients who return to ED and to a physician within 48 hours.

  5. Nausea level [ Time Frame: 12 hours ]
    Improvement of patient comfort evaluated by parents according to a Baxter Animated Retching Face Scale (BARF) scale

  6. Alternative diagnosis [ Time Frame: 12 hours ]
    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

  7. Left without being sen [ Time Frame: 12 hours ]
    The investigator will compare the proportion of children who left the ED without being seen by a physician.

  8. Rescue medication [ Time Frame: 12 hours ]
    The proportion of children requiring a rescue medication for persistent nausea/vomiting



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052361


Locations
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Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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Principal Investigator: Jocelyn Gravel, MD Sainte-Justine Hospital
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Responsible Party: Jocelyn Gravel, Principal investigator, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03052361    
Other Study ID Numbers: Ondansetron at triage
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jocelyn Gravel, St. Justine's Hospital:
Children
emergency department
ondansetron
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents