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

• ClinicalTrials.gov Identifier: NCT01575600
• Recruitment Status: Completed
• First Posted: April 11, 2012
• Last Update Posted: May 10, 2012
• Sponsor: Ignacio Cortínez F.
• Information provided by (Responsible Party): Ignacio Cortínez F., Pontificia Universidad Catolica de Chile

Tracking Information

• First Submitted Date: April 10, 2012
• First Posted Date: April 11, 2012
• Last Update Posted Date: May 10, 2012
• Study Start Date: July 2010
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Postoperative Vomiting

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 10, 2012): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Chile

Administrative Information

• NCT Number: NCT01575600
• Other Study ID Numbers: 10-095
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ignacio Cortínez F., Pontificia Universidad Catolica de Chile
• Study Sponsor: Ignacio Cortínez F.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pontificia Universidad Catolica de Chile
• Verification Date: May 2012