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NCT Number: NCT07489742

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

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

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Key information

Conditions

Ondansetron Intravenous Lozenge Shivering Tonsillectomy

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Mohammed S Elsharkawy, MD

CONTACT

[email protected]

00201148207870

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ondansetron lozenge

Drug

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

Ondansetron intravenous

Drug

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

Primary outcomes

  1. Incidence of shivering

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: 24 hours postoperatively

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

  2. Core temperature

    Time frame: Intraoperatively

    Core temperature will be recorded.

  3. Peripheral temperature

    Time frame: Intraoperatively

    Peripheral temperature will be recorded.

  4. Incidence of adverse effects

    Time frame: 24 hours postoperatively

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed S Elsharkawy, MD

CONTACT

[email protected]

00201148207870

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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