Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?

Not Applicable

Completed

• Conditions: Post-operative Vomiting
• Interventions: Other: Water; Other: Apple Juice

• Registration Number: NCT01725399
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a medicine called ondansetron (Zofran), is in dire national shortage. Consequently, non-pharmacological methods of prevention and treatment for post-operative nausea and vomiting have increased import. Following emergence from general anesthesia, children often request food and drink. There have been no studies to date that definitively determine the optimal first food or drink choice for these children. This study proposes to randomize children to either water or juice first intake following surgery. The investigators expect to find that children who consume glucose are less likely to vomit than those who first receive water.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• Dental surgery
• Tonsillectomy and adenoidectomy
• Strabismus surgery
• Age 2-18

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Exclusion Criteria

• Patient refusal
• Parent refusal
• Allergy / contraindication to ondansetron
• Prone to vomiting
• Inpatient
• Preoperative anxiolysis with ketamine
• Recovery location other than PACU
• Nil per os at baseline
• Presence of enteric tube
• Contraindication to any part of the study protocol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Water	Water	Water will be given as the study subject's first oral intake after emergence from general anesthesia.
Apple Juice	Apple Juice	Apple juice will be given as the study subject's first oral intake after emergence from general anesthesia.

Primary Outcome Measures

Name	Time	Method
Post-operative Vomiting	24 hr post-op	Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.

Trial Locations

Locations (1)

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States