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

NCT01575600 | Completed Phase 3

• 1 other identifier: 10-095
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Vomiting

Outcome Measures

Primary Outcomes (1)

• Vomiting at 24 hours postoperative

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

  First 24 hours postoperative

Study Arms (2)

10 mL/kg/h lactated Ringer's solution

ACTIVE COMPARATOR

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

Other: Intraoperative lactated Ringer's solution

30 mL/kg/h lactated Ringer's solution

EXPERIMENTAL

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

Other: Intraoperative lactated Ringer's solution

Interventions

Intraoperative lactated Ringer's solution OTHER

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.

10 mL/kg/h lactated Ringer's solution; 30 mL/kg/h lactated Ringer's solution

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I or II
• Age 1-12 yr
• Scheduled for elective tonsillectomy or adenotonsillectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ignacio Cortínez F.: lead

Study Sites (1)

Hospital Clinico Universidad Catolica

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Profesor Asociado, Departamento de Anestesiología

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 11, 2012
• Study Start: July 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

CL (1)