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NCT Number: NCT06423820

Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries

The aim of this study is to evaluate the role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries.

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Key information

About this study

Post-operative nausea and vomiting (PONV) are two of the most common and distressing complications related to surgery and anesthesia.

In several studies PONV occurred in 13% to 42% of pediatric surgical patients, while severe cases are less common, occurring in 1-3% of patients. Volatile anesthetics are the main cause in the early post-operative period (0-2 h), with dose-response relationship. In the delayed post-operative period (2-24 h) the main predictors are childhood, PONV in the early period, and the use of postoperative opioids.

Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects.

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.
  • American Society of Anesthesiology (ASA) physical status I, II.
  • Pediatric patients undergoing squint surgeries.

Exclusion criteria

  • Patients who had received any medication with antiemetic properties within 24 h before surgery.
  • Post-operative period (for reasons other than rescue antiemetic therapy).
  • Patients with known liver or renal disease.
  • Patients with a history of vomiting or retching within 24 h before surgery.

Treatment and study plan

Ondansetron lozenge

Drug

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

Primary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: 24 hours postoperatively

    The incidence of postoperative nausea and vomiting (PONV) will be measured in the first 24 postoperative hours at the intervals of 0-2h (early PONV), 2-12h (delayed PONV), and 12- 24h (late PONV)

Secondary outcomes

  1. Severity of postoperative nausea and vomiting (PONV)

    Time frame: 24 hours postoperatively

    The severity of postoperative nausea and vomiting (PONV) will be scored as follows: [0 = no nausea and no retching; 1 complaining of sickness and retching; vomiting one or two times in 30 min; and 3 vomiting more than two times in 30 min] in the first 24 hours postoperatively.

  2. Number of emetic episodes

    Time frame: 24 hours postoperatively

    Number of emetic episodes will be measured from the end of surgery till 24 hours postoperatively.

  3. Time to onset of emesis

    Time frame: 24 hours postoperatively

    Time to onset of emesis will be measured from the end of surgery till 24 hours postoperatively.

  4. Incidence of oculo-cardiac reflex (OCR)

    Time frame: 24 hours postoperatively

    Incidence of oculo-cardiac reflex (OCR) will be recorded. OCR is defined as a 10-20% decrease in the resting heart rate and/or the occurrence of any arrhythmia.

  5. Parental satisfaction

    Time frame: 24 hours postoperatively

    Degree of parental satisfaction by using an 11-pointverbal numeric scoring system (0 = not at all satisfied, 10 = fully satisfied).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 21, 2024
Registry last updated
Jan 30, 2025

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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