The effect of ondansetron on persisting vomitin in children with gastro-enteritis presenting at primary care out of hours service.

THE ADDED EFFECT OF ORAL ONDANSETRON TO CARE-AS-USUAL ON PERSISTING VOMITING IN CHILDREN AGED 6 MONTHS TO 6 YEARS, PRESENTING AT PRIMARY CARE OUT OF HOURS SERVICE WITH ACUTE GASTRO-ENTERITIS AND CONCOMITANT VOMITING

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26937

Enrollment

220

Registered

2016-09-01

Start date

2016-11-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huisartsgeneeskunde (General Practice), Kinderen (Children), Gastro-enteritis (gastroenteritis), Kosteneffectiviteit (cost-effectiveness), Misselijkheid (vomiting)

Interventions

Weight-based dose of oral ondansetron added to oral rehydration therapy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged 6 months to 6 years; 2. At least four reported episodes of vomiting or diarrhoea during the last twenty-four hours preceding presentation 3. At least one reported episode of vomiting within the four hours preceding presentation; 4. Diagnosed with AGE by a general practitioner at the OHS. 5. Parental written informed consent.

Exclusion criteria

Exclusion criteria: 1. Use of anti-emetics in the previous 6 hours; 2. Known renal failure or hypoalbuminemia (as this could affect the assessment of hydration status); 3. Known diabetes mellitus or inflammatory bowel disease (as this could increase the risk of a complicated course); 4. A history of abdominal surgery, with suspected recurrence of original abdominal symptoms or strangulation ileus explaining current symptoms, according to the general practitioner. 5. Known sensitivity to 5-HT3 receptor antagonists; 6. Known prolonged QT interval; 7. Current use of QT prolonging medication; 8. Previous enrolment in the study.

Design outcomes

Primary

Measure	Time frame
The proportion of children that continue to vomit within the first 4 hours after presentation at the OHS with acute gastro-enteritis.	—

Secondary

Measure	Time frame
Cessation of vomiting, the number of vomiting episodes during ORT, referral to a (pediatric) emergency department), intravenous rehydration, hospital admission rate and duration, healthcare use and costs. A vomiting episode will be recorded by the parent when a forceful expulsion of stomach contents occurs. Episodes separated by no more than two minutes will be counted as a single episode. Nonproductive retching, spilling of oral contents, and drooling are not considered vomiting. Cessation of vomiting will be noted at the time of a vomiting episode after which no more than 1 vomiting episode is noted during a period of at least 1 day.	—

Measure

Time frame

Cessation of vomiting, the number of vomiting episodes during ORT, referral to a (pediatric) emergency department), intravenous rehydration, hospital admission rate and duration, healthcare use and costs. A vomiting episode will be recorded by the parent when a forceful expulsion of stomach contents occurs. Episodes separated by no more than two minutes will be counted as a single episode. Nonproductive retching, spilling of oral contents, and drooling are not considered vomiting. Cessation of vomiting will be noted at the time of a vomiting episode after which no more than 1 vomiting episode is noted during a period of at least 1 day.

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Contacts

Public ContactM.Y. Berger

Universitair Medisch Centrum Groningen

Email: m.y.berger@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)