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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group S (Ondansetron lozenge) | Experimental | Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group. |
|
| Group C (Control) | No Intervention | Pediatric patients will not receive ondansetron as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron lozenge | Drug | Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41642273 | Derived | Moharam SA, Elsharkawy MS, Zahra SW, Hamama K, Elshikh A, Mahmoud ME, Elsaily AS, Elfatah HF, Shalan FS. Preoperative ondansetron lozenge for prevention of postoperative nausea and vomiting in pediatrics undergoing squint surgeries: a randomized controlled trial. Minerva Anestesiol. 2026 May;92(5):427-434. doi: 10.23736/S0375-9393.26.19496-6. Epub 2026 Feb 5. |
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The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Number of emetic episodes | Number of emetic episodes will be measured from the end of surgery till 24 hours postoperatively. | 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. | 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. | 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). | 24 hours postoperatively |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D013285 | Strabismus |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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