An interventional study of Ondansetron lozenge in Ondansetron Lozenge, Postoperative Nausea and Vomiting and Pediatrics, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Tanta University · Not applicable, Interventional, and Prevention
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.
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.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's enrollment of 80 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group.
Drug: Ondansetron lozenge
Pediatric patients will not receive ondansetron as a control group.
Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
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)
Time frame: 24 hours postoperatively
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.
Time frame: 24 hours postoperatively
Number of emetic episodes
Number of emetic episodes will be measured from the end of surgery till 24 hours postoperatively.
Time frame: 24 hours postoperatively
Time to onset of emesis
Time to onset of emesis will be measured from the end of surgery till 24 hours postoperatively.
Time frame: 24 hours postoperatively
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.
Time frame: 24 hours postoperatively
Parental satisfaction
Degree of parental satisfaction by using an 11-pointverbal numeric scoring system (0 = not at all satisfied, 10 = fully satisfied).
Time frame: 24 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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