Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal Fluminense
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Palonosetron

Criteria

Inclusion Criteria:

• Children undergoing elective strabismus surgery

• Physical state according to an American Society of Anesthesiologists (ASA) I and II

Exclusion Criteria:

• Children nor involved in surgery

• Participation in another study in the last month

• Previous history of PONV

• Occurrence of episodes of nausea or vomiting in the last 24 hours before surgery

• Chronic use of corticosteroids

• Previous history of motion sickness

• Use of psychoactive drugs or any other medicine with an antiemetic effect;

• Known hypersensitivity to any study medication

• Severe diseases in organs such as kidney, liver, lung, heart, brain and bone marrow