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

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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

Tracking Information
First Submitted Date  ICMJE April 10, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date May 10, 2012
Study Start Date  ICMJE July 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Official Title  ICMJE Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Postoperative Vomiting
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: 10 mL/kg/h lactated Ringer's solution
    Group 1, 10 mL/kg/h lactated Ringer's solution
    Intervention: Other: Intraoperative lactated Ringer's solution
  • Experimental: 30 mL/kg/h lactated Ringer's solution
    Group 2, 30 mL/kg/h lactated Ringer's solution
    Intervention: Other: Intraoperative lactated Ringer's solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2012)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575600
Other Study ID Numbers  ICMJE 10-095
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ignacio Cortínez F., Pontificia Universidad Catolica de Chile
Study Sponsor  ICMJE Ignacio Cortínez F.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pontificia Universidad Catolica de Chile
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP