Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

Tanta University210 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Ondansetron Lozenge Intravenous Shivering Tonsillectomy

Interventions

Ondansetron lozengeDRUG

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

Ondansetron intravenousDRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 15 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 24 hours postoperatively

Secondary Outcomes

Incidence of postoperative nausea and vomiting

Incidence of postoperative nausea and vomiting (PONV) will be recorded.

Time frame: 24 hours postoperatively

Core temperature

Core temperature will be recorded.

Time frame: Intraoperatively

Peripheral temperature

Peripheral temperature will be recorded.

Time frame: Intraoperatively

Incidence of adverse effects

Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.

Time frame: 24 hours postoperatively

Central Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870 mselsharkawy@med.tanta.edu.eg

Data from ClinicalTrials.gov

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