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Recruiting Not applicable

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

NCT07489742 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-03-25
Last updated
2026-03-27

Condition(s) studied

OndansetronLozengeIntravenousShiveringTonsillectomy

Investigational drug(s) / intervention(s)

Ondansetron lozenge →Ondansetron intravenous →

Ondansetron lozenge: Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.

Ondansetron intravenous: Patients will receive 4 mg of ondansetron IV just before the surgery.

Study summary

This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in tonsillectomy.

Eligibility

Sex
ALL
Min age
4 Years
Max age
15 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of shivering — 24 hours postoperatively
    Incidence of shivering will be recorded and graded by using the scale validated by Crossley and Mahajan. Crossley and Mahajan grade 0, no shivering; grade 1, no visible muscle activity, but one or more of the following: piloerection, peripheral vasoconstriction, or peripheral cyanosis (other causes excluded); grade 2, muscular activity in only one muscle group; grade 3, moderate muscular activity in more than one muscle group but not generalized shaking; grade 4, violent muscular activity that involves the whole body.

Trial sites (1)

FacilityCityRegionStatus
Tanta University Tanta El-Gharbia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07489742 on ClinicalTrials.gov ↗ ← All trials in Egypt