Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Vomiting at 24 hours postoperative
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ignacio Cortínez F.
Profesor Asociado, Departamento de Anestesiología
Pontificia Universidad Catolica de Chile