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

Primary Purpose

Postoperative Vomiting

Status
Completed
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Intraoperative lactated Ringer's solution
Sponsored by
Ignacio Cortínez F.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Vomiting

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinico Universidad Catolica

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

10 mL/kg/h lactated Ringer's solution

30 mL/kg/h lactated Ringer's solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 10, 2012
Last Updated
May 8, 2012
Sponsor
Ignacio Cortínez F.
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1. Study Identification

Unique Protocol Identification Number
NCT01575600
Brief Title
Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Official Title
Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ignacio Cortínez F.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mL/kg/h lactated Ringer's solution
Arm Type
Active Comparator
Arm Description
Group 1, 10 mL/kg/h lactated Ringer's solution
Arm Title
30 mL/kg/h lactated Ringer's solution
Arm Type
Experimental
Arm Description
Group 2, 30 mL/kg/h lactated Ringer's solution
Intervention Type
Other
Intervention Name(s)
Intraoperative lactated Ringer's solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vomiting at 24 hours postoperative
Description
Presence of at least one episode of vomiting in the first 24 hours postoperative
Time Frame
First 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Clinico Universidad Catolica
City
Santiago
State/Province
Region Metropolitana
Country
Chile

12. IPD Sharing Statement

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

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