NCT07489742

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 4 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Tonsillectomy is one of the most common surgeries in children. The main reason for morbidity in patients undergoing surgical procedures is post-operative complications. Shivering is random spontaneous and asynchronous skeletal muscle contractions that increases the basal metabolism and is characterized to be a defense mechanism for regulation of temperature. Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation.

Conditions

• Ondansetron
• Lozenge
• Intravenous
• Shivering
• Tonsillectomy

Interventions

Type	Name	Description
DRUG	Ondansetron lozenge	Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
DRUG	Ondansetron intravenous	Patients will receive 4 mg of ondansetron IV just before the surgery.

Timeline

• Start date: 2026-03-25
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-03-24
• Last updated: 2026-03-27

Locations

1 site across 1 country: Egypt