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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423820
• Other study ID #: 36264PR640/4/24
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: Mohammed S Elsharkawy, MD
• Phone: 00201148207870
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Pediatrics
• Postoperative Nausea and Vomiting
• Strabismus
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of postoperative nausea and vomiting (PONV)	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.	24 hours postoperatively
Secondary	Number of emetic episodes	Number of emetic episodes will be measured from the end of surgery till 24 hours postoperatively.	24 hours postoperatively
Secondary	Time to onset of emesis	Time to onset of emesis will be measured from the end of surgery till 24 hours postoperatively.	24 hours postoperatively
Secondary	Incidence of oculo-cardiac reflex (OCR)	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.	24 hours postoperatively
Secondary	Parental satisfaction	Degree of parental satisfaction by using an 11-pointverbal numeric scoring system (0 = not at all satisfied, 10 = fully satisfied).	24 hours postoperatively