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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01575600
• Date of registration: 10/04/2012
• Prospective Registration: No
• Primary sponsor: Ignacio Cortínez F.
• Public title: Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
• Scientific title: Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
• Date of first enrolment: July 2010
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01575600
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
• Phase: Phase 3

Countries of recruitment

Chile

Key inclusion & exclusion 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



Age minimum: 1 Year
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative Vomiting

Intervention(s)

Other: Intraoperative lactated Ringer's solution

Primary Outcome(s)

Vomiting at 24 hours postoperative [Time Frame: First 24 hours postoperative]

Secondary ID(s)

10-095

Source(s) of Monetary Support

Please refer to primary and secondary sponsors