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Clinical Trials/NCT01575600
NCT01575600
Completed
Phase 3

Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery

Ignacio Cortínez F.1 site in 1 country100 target enrollmentJuly 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Postoperative Vomiting
Sponsor
Ignacio Cortínez F.
Enrollment
100
Locations
1
Primary Endpoint
Vomiting at 24 hours postoperative
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this randomized clinical trial is to evaluate the interaction of intravenous fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The hypothesis is that perioperative supplemental intravenous fluid administration reduces the incidence of postoperative vomiting.

Detailed Description

Postoperative vomiting is a common complication on pediatric surgery, especially otorhinolaryngological surgery. Is one of the main reasons of prolonged hospital stay, and also a cause of patient´s discomfort and an increase on hospitalization cost. There are studies in adults with inconclusive results related to supplemental fluid therapy and decrease of postoperative nausea and vomiting. But, in recent years a study in children showed favorable results in strabismus surgery. The foundation of this study consist in that hypovolemia may possibly cause a decrease in perfusion causing intestinal hypoxia, which in turn increase the incidence of nausea and vomiting. The objective of this study is to observe the effect of supplemental fluid therapy on postoperative vomiting on otorhinolaryngological surgery.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
March 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ignacio Cortínez F.
Responsible Party
Sponsor Investigator
Principal Investigator

Ignacio Cortínez F.

Profesor Asociado, Departamento de Anestesiología

Pontificia Universidad Catolica de Chile

Eligibility Criteria

Inclusion Criteria

  • ASA physical status I or II
  • Age 1-12 yr
  • Scheduled for elective tonsillectomy or adenotonsillectomy

Exclusion Criteria

  • History of diabetes
  • History of mental retardation
  • Obesity (BMI ≥95th percentile for age and sex)
  • Intake of antiemetic or psychoactive medication within 24 hours before surgery
  • Known gastroesophageal reflux

Outcomes

Primary Outcomes

Vomiting at 24 hours postoperative

Time Frame: First 24 hours postoperative

Presence of at least one episode of vomiting in the first 24 hours postoperative

Study Sites (1)

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