Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

Tanta University

Status: Enrolling

Conditions: Intravenous; Tonsillectomy; Shivering; Lozenge; Ondansetron

Treatments: Drug: Ondansetron lozenge; Drug: Ondansetron intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT07489742

36264PR131011017/2/26

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 4 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Group L

Experimental group

Description:

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

Treatment:

Drug: Ondansetron lozenge

Group O

Experimental group

Description:

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

Treatment:

Drug: Ondansetron intravenous

Group C

No Intervention group

Description:

Patients will not receive ondansetron as a control group.