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

Phase 3

Completed

• Conditions: Postoperative Vomiting
• Interventions: Other: Intraoperative lactated Ringer's solution

• Registration Number: NCT01575600
• Lead Sponsor: Ignacio Cortínez F.

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 Timeline

• Study Start: 2010-07
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mL/kg/h lactated Ringer's solution	Intraoperative lactated Ringer's solution	Group 1, 10 mL/kg/h lactated Ringer's solution
30 mL/kg/h lactated Ringer's solution	Intraoperative lactated Ringer's solution	Group 2, 30 mL/kg/h lactated Ringer's solution

Primary Outcome Measures

Name	Time	Method
Vomiting at 24 hours postoperative	First 24 hours postoperative	Presence of at least one episode of vomiting in the first 24 hours postoperative

Trial Locations

Locations (1)

Hospital Clinico Universidad Catolica; 🇨🇱 Santiago, Region Metropolitana, Chile