Ondansetron lozenge versus IV to prevent shivering after tonsil removal in children
Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 4 Years to 15 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07489742 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous research has shown ondansetron can reduce perioperative shivering, though the lozenge route, especially in children, is less widely studied.
Eligibility criteria
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 this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.