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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575600
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Ignacio Cortínez F., Pontificia Universidad Catolica de Chile

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Vomiting Other: Intraoperative lactated Ringer's solution Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Study Start Date : July 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 10 mL/kg/h lactated Ringer's solution
Group 1, 10 mL/kg/h lactated Ringer's solution
 Other: 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.
Experimental: 30 mL/kg/h lactated Ringer's solution
Group 2, 30 mL/kg/h lactated Ringer's solution
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575600


Locations
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Chile
Hospital Clinico Universidad Catolica
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
Ignacio Cortínez F.
More Information
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Responsible Party: Ignacio Cortínez F., Profesor Asociado, Departamento de Anestesiología, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01575600    
Other Study ID Numbers: 10-095
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
 Postoperative Complications
Pathologic Processes
Nausea