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

Ignacio Cortínez F.

Status and phase: Completed; Phase 3

Conditions: Postoperative Vomiting

Treatments: Other: Intraoperative lactated Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01575600

10-095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

10 mL/kg/h lactated Ringer's solution

Active Comparator group

Description:

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

Treatment:

Other: Intraoperative lactated Ringer's solution

30 mL/kg/h lactated Ringer's solution

Experimental group

Description:

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

Treatment:

Other: Intraoperative lactated Ringer's solution