Ondansetron lozenge versus IV to prevent shivering after tonsil removal in children
Official title: Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy: A Randomized Controlled Trial
Run by Tanta University · NCT07489742 · Data updated 2026-11-12
This test will see if an ondansetron lozenge works as well as intravenous ondansetron to prevent shivering in children aged 4 to 15 having a tonsillectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 15 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Status | Recruiting |
| Started | March 25, 2026 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07489742 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4 to 15 of either sex who are ASA physical status I–II and scheduled for tonsillectomy under general anesthesia, without ondansetron allergy or excluded comorbidities, are ideal candidates.
✕Probably not a fit
Patients outside the 4–15 age range, those with ondansetron allergy, sleep apnea, cardiac or respiratory disease, current upper respiratory infection, or on corticosteroids are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children aged 4–15 undergoing tonsillectomy under general anesthesia at Tanta University will receive either an ondansetron lozenge or intravenous ondansetron and be monitored for intra- and post-operative shivering. The trial enrolls ASA I–II patients and excludes those with ondansetron allergy, sleep apnea, cardiac or respiratory disease, current upper respiratory infection, or corticosteroid use. Outcomes will include incidence and severity of shivering and related postoperative recovery measures. The comparison aims to determine whether a noninvasive lozenge route offers similar protection against shivering as the IV route.
Why it matters
Potential benefit: If successful, patients could experience less postoperative shivering and greater comfort with a simpler lozenge option instead of an IV dose.
How similar studies have gone: Previous research has shown ondansetron can reduce perioperative shivering, though the lozenge route, especially in children, is less widely studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 4 to 15 years. * Both sexes. * American Society of Anesthesiology (ASA) physical status I-II. * Children undergoing tonsillectomy under general anesthesia. Exclusion Criteria: * Allergy to ondansetron. * History of sleep apnea. * Cardiac and respiratory diseases. * Upper respiratory tract infection. * Taking corticosteroids.
Where it's running
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Tanta University
Tanta, El-Gharbia, Egypt Recruiting
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.