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

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

Study Overview

• Status: Recruiting
• Conditions: Tonsillectomy; Shivering; Ondansetron; Intravenous; Lozenge
• Intervention / Treatment: Drug: Ondansetron lozenge; Drug: Ondansetron intravenous

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta university
      • Contact: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group L; Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.	Drug: Ondansetron lozenge; Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Experimental: Group O; Patients will receive 4 mg of ondansetron IV just before the surgery.	Drug: Ondansetron intravenous; Patients will receive 4 mg of ondansetron IV just before the surgery.
No Intervention: Group C; Patients will not receive ondansetron as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting (PONV) will be recorded.	24 hours postoperatively
Core temperature	Core temperature will be recorded.	Intraoperatively
Peripheral temperature	Peripheral temperature will be recorded.	Intraoperatively
Incidence of adverse effects	Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 36264PR131011017/2/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No