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

NCT ID: NCT01575600

Last Updated: 2012-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-03-31

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.

Conditions

Postoperative Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

10 mL/kg/h lactated Ringer's solution

Group 1, 10 mL/kg/h lactated Ringer's solution

Group Type: ACTIVE_COMPARATOR

Intraoperative lactated Ringer's solution

Intervention Type: OTHER

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.

30 mL/kg/h lactated Ringer's solution

Group 2, 30 mL/kg/h lactated Ringer's solution

Group Type: EXPERIMENTAL

Intraoperative lactated Ringer's solution

Intervention Type: OTHER

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.

Interventions

Intraoperative lactated Ringer's solution

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ignacio Cortínez F.

OTHER

Sponsor Role: lead

Responsible Party

Ignacio Cortínez F.

Profesor Asociado, Departamento de Anestesiología

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Clinico Universidad Catolica

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Other Identifiers

10-095

Identifier Type: -

Identifier Source: org_study_id