Ondansetron Lozenge, Pediatrics, Postoperative Nausea and Vomiting, Squint
Conditions
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.
Detailed 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.
Interventions
Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting | 24 hours postoperatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of postoperative nausea and vomiting (PONV) | 24 hours postoperatively | 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. |
| Number of emetic episodes | 24 hours postoperatively | Number of emetic episodes will be measured from the end of surgery till 24 hours postoperatively. |
| Time to onset of emesis | 24 hours postoperatively | Time to onset of emesis will be measured from the end of surgery till 24 hours postoperatively. |
| Incidence of oculo-cardiac reflex (OCR) | 24 hours postoperatively | 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. |
| Parental satisfaction | 24 hours postoperatively | Degree of parental satisfaction by using an 11-pointverbal numeric scoring system (0 = not at all satisfied, 10 = fully satisfied). |
Countries
Egypt
Outcome results
None listed