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

NCT04060771 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-08-19

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Strabismus
  • PONV

Interventions

DRUG

Palonosetron

prophylaxis of postoperative nausea and vomiting

DRUG

Dexamethasone

prophylaxis of postoperative nausea and vomiting

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Principal Investigators

  • Júlio CA Moreira, MD · Hospital Universitário Antonio Pedro

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-11-01
Completion
2020-07-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04060771 on ClinicalTrials.gov