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The effect of ondansetron on referral rate in children with gastro-enteritis and vomiting.

The effect of oral ondansetron on referral rate in children aged 6 months to 6 years attending in primary care out of hours service with acute gastro-enteritis and vomiting.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21316
Enrollment
1064
Registered
2014-11-06
Start date
2015-10-19
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

General practice, Paediatrics, Acute gastroenteritis, Child, Cost-effectiveness, Antiemetic

Interventions

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged 6 months to 6 years; 2. At least 24 hours with episodes of nonbilious, nonbloody vomiting; 3. At least one reported episode of vomiting within the four hours preceding presentation; 4. At least one episode of diarrhea during the period of illness; 5. Parental written informed consent.

Exclusion criteria

Exclusion criteria: 1. Requiring direct referral to an emergency department according to GP; 2. Use of anti-emetics in the previous 6 hours; 3. Known renal failure or hypoalbuminemia (as this could affect the assessment of hydration status); 4. Known diabetes mellitus or inflammatory bowel disease (as this could increse the risk of a complicated course); 5. A history of abdominal surgery; 6. Known sensitivity to 5-HT3 receptor antagonists; 7. Known prolonged QT-interval; 8. Current use of QT-prolonging medication; 9. Previous enrolment in the study.

Design outcomes

Secondary

MeasureTime frame
Cessation of vomiting, the number of vomiting episodes during ORT, 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.

Primary

MeasureTime frame
The proportion of referrals to a (paediatric) emergency department over a period of 5 days.

Contacts

Public ContactY. Lisman-van Leeuwen

UMCG, afdeling huisartsgeneeskunde

y.lisman-van.leeuwen@umcg.nl050-3637525

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)