Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

NCT07489742 | Recruiting

• 1 other identifier: 36264PR131011017/2/26
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ondansetron; Lozenge; Intravenous; Shivering; Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of shivering

  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.

  24 hours postoperatively

Secondary Outcomes (4)

• Incidence of postoperative nausea and vomiting

  24 hours postoperatively

• Core temperature

  Intraoperatively

• Peripheral temperature

  Intraoperatively

• Incidence of adverse effects

  24 hours postoperatively

Study Arms (3)

Group L

EXPERIMENTAL

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

Drug: Ondansetron lozenge

Group O

EXPERIMENTAL

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

Drug: Ondansetron intravenous

Group C

NO INTERVENTION

Patients will not receive ondansetron as a control group.

Interventions

Ondansetron lozenge DRUG

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

Group L

Ondansetron intravenous DRUG

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

Group O

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 4 to 15 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Children undergoing tonsillectomy under general anesthesia.

You may not qualify if:

• Allergy to ondansetron.
• History of sleep apnea.
• Cardiac and respiratory diseases.
• Upper respiratory tract infection.
• Taking corticosteroids.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870; mselsharkawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)