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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Tanta University
Tanta, El-Gharbia, Egypt
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
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