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

University of North Carolina (UNC)

Status: Completed

Conditions: Post-operative Vomiting

Treatments: Other: Water; Other: Apple Juice

Study type: Interventional

Funder types: Other

Identifiers

NCT01725399

12-1792

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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183 participants in 2 patient groups, including a placebo group

Water

Placebo Comparator group

Description:

Water will be given as the study subject's first oral intake after emergence from general anesthesia.

Treatment:

Other: Water

Apple Juice

Experimental group

Description:

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

Treatment:

Other: Apple Juice