Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce.
Prospective, double-blind study comparing Palonosetron and Dexamethasone in the prophylaxis of Post-Operative Nausea and Vomiting in children submitted to Strabismus surgery ABSTRACT Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce. Objective: The study aims to compare the incidence of PONV after intravenous administration of palonosetron or dexamethasone in pediatric patients undergoing elective strabismus surgery under general anesthesia. Materials and Methods: This prospective, double-blind study consist of 80 patients of both genders, classified as ASA grade I and II, ranging in age from 2 to 15 years, scheduled for elective strabismus surgery at Hospital Universitário Antonio Pedro(HUAP), after consent by their parents. Patients will be randomized into two groups of 40 patients each. Group P will receive intravenous dose of palonosetron (1 mg.kg-1), and Group D will receive dexamethasone (0.2 mg.kg-1) after induction of anesthesia. Pacients will be observed for 6 hours before discharge and post-discharge symptoms will be assessed through telephone survey after 24 and 48 hours. At the end of the study, results will be compiled and statistical analysis will be done by using Mann-Whitney test, Chi-squared test and Fisher test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
80
prophylaxis of postoperative nausea and vomiting
prophylaxis of postoperative nausea and vomiting
Hospital Universitário Antonio Pedro
Niterói, Rio de Janeiro, Brazil
RECRUITINGVomiting
Quantify the frequency of individual episodes of vomiting at the first 48 hours after surgery.
Time frame: 48 hours postoperative
Vomiting
Quantify the frequency of individual episodes of vomiting at the first 24 hours after surgery.
Time frame: 24 hours postoperative
Vomiting
Quantify the frequency of individual episodes of vomiting at the first 6 hours after surgery.
Time frame: 6 hours postoperative
Vomiting
Quantify the frequency of individual episodes of vomiting at the first 2 hours after surgery.
Time frame: 2 hours postoperative
Nausea
Quantify the frequency of episodes of nausea at the first 48 hours after surgery.
Time frame: 48 hours postoperative
Nausea
Quantify the frequency of episodes of nausea at the first 24 hours after surgery.
Time frame: 24h hours postoperative
Nausea
Quantify the frequency of episodes of nausea at the first 6 hours after surgery.
Time frame: 6h hours postoperative
Nausea
Quantify the frequency of episodes of nausea at the first 2 hours after surgery.
Time frame: 2h hours postoperative
Check adverse effects
Check the frequency of adverse events (headache, dizziness, drowsiness).
Time frame: 48 hours postoperative
Treatment cost
Price evaluation of antiemetic drugs.
Time frame: 48 hours postoperative
Response to medication
Quantify the number of complete responders (individuals who did not have an episode of PONV and did not require rescue medication).
Time frame: 48 hours postoperative
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