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

NCT ID: NCT06423820

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2025-01-23

Brief Summary

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.

Detailed 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.

Conditions

Ondansetron Lozenge; Postoperative Nausea and Vomiting; Pediatrics; Squint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group S (Ondansetron lozenge)

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

Group Type: EXPERIMENTAL

Ondansetron lozenge

Intervention Type: DRUG

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

Group C (Control)

Pediatric patients will not receive ondansetron as a control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ondansetron lozenge

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR640/4/24

Identifier Type: -

Identifier Source: org_study_id