Clinical trial

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

Name
36264PR640/4/24
Description
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.
Trial arms
Trial start
2024-05-21
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Treatment
Ondansetron lozenge
Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Arms:
Group S (Ondansetron lozenge)
Size
80
Primary endpoint
Incidence of postoperative nausea and vomiting
24 hours postoperatively
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-05-22

1 organization

1 product

4 indications

Organization
Tanta University
Indication
Pediatrics
Indication
Strabismus