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

Postoperative Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575600
• Other study ID #: 10-095
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2012
• Last updated: May 8, 2012
• Start date: July 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: International Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• 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.

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad Catolica	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Ignacio Cortínez F.

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vomiting at 24 hours postoperative	Presence of at least one episode of vomiting in the first 24 hours postoperative	First 24 hours postoperative	No