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

Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01725399
Acronym
XOndansetron
Enrollment
183
Registered
2012-11-12
Start date
2012-10-31
Completion date
2013-12-31
Last updated
2014-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Vomiting

Keywords

post-operative vomiting

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.

Interventions

OTHERWater

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative Vomiting24 hr post-opPatients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026