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

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.

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Key information

Conditions

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

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinico Universidad Catolica

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Ignacio Cortínez F.

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Apr 11, 2012
Registry last updated: May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed