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

NCT06423820 | Completed

• 1 other identifier: 36264PR640/4/24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ondansetron Lozenge; Postoperative Nausea and Vomiting; Pediatrics; Squint

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting

  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)

  24 hours postoperatively

Secondary Outcomes (5)

• Severity of postoperative nausea and vomiting (PONV)

  24 hours postoperatively

• Number of emetic episodes

  24 hours postoperatively

• Time to onset of emesis

  24 hours postoperatively

• Incidence of oculo-cardiac reflex (OCR)

  24 hours postoperatively

• Parental satisfaction

  24 hours postoperatively

Study Arms (2)

Group S (Ondansetron lozenge)

EXPERIMENTAL

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

Drug: Ondansetron lozenge

Group C (Control)

NO INTERVENTION

Pediatric patients will not receive ondansetron as a control group.

Interventions

Ondansetron lozenge DRUG

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

Group S (Ondansetron lozenge)

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 4 to 15 years.
• American Society of Anesthesiology (ASA) physical status I, II.
• Pediatric patients undergoing squint surgeries.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Strabismus

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: May 21, 2024
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)