Clinical trial Recruiting at 1 site Interventional Ages 4 to 15

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.

More Tonsillectomy trials

Quick facts

Study typeInterventional
Ages4 Years to 15 Years
SexAll
Enrollment210 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta, El-Gharbia)
StatusRecruiting
StartedMarch 25, 2026
Main results expectedSeptember 1, 2026
Study endsSeptember 1, 2026
Registry record updatedMarch 27, 2026
Trial IDNCT07489742 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

  • Tanta University
    Tanta, El-Gharbia, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.