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

Tanta University

Status: Completed

Conditions: Pediatrics; Ondansetron Lozenge; Squint; Postoperative Nausea and Vomiting

Treatments: Drug: Ondansetron lozenge

Study type: Interventional

Funder types: Other

Identifiers

NCT06423820

36264PR640/4/24

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 4 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group S (Ondansetron lozenge)

Experimental group

Description:

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

Treatment:

Drug: Ondansetron lozenge

Group C (Control)

No Intervention group

Description:

Pediatric patients will not receive ondansetron as a control group.