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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Vomiting

Intervention / Treatment
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* Other: Intraoperative lactated Ringer's solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 mL/kg/h lactated Ringer's solution<br>Group 1, 10 mL/kg/h lactated Ringer's solution | Other: Intraoperative lactated Ringer's solution<br>* After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.<br>|
| Experimental: 30 mL/kg/h lactated Ringer's solution<br>Group 2, 30 mL/kg/h lactated Ringer's solution | Other: Intraoperative lactated Ringer's solution<br>* After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vomiting at 24 hours postoperative | Presence of at least one episode of vomiting in the first 24 hours postoperative | First 24 hours postoperative |