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Recruiting NCT07489742

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

No phase Interventional Ondansetron Lozenge Intravenous Shivering

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ondansetron lozenge, Ondansetron intravenous.
Who it may be relevant to
Registry conditions: Ondansetron, Lozenge, Intravenous, Shivering. Basic parameters: 4 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Incidence of shivering [Time frame: 24 hours postoperatively]
Secondary outcome measures (4)
  • Incidence of postoperative nausea and vomiting [Time frame: 24 hours postoperatively]
  • Core temperature [Time frame: Intraoperatively]
  • Peripheral temperature [Time frame: Intraoperatively]
  • Incidence of adverse effects [Time frame: 24 hours postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07489742 · 36264PR131011017/2/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗