Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?
XOndansetron
Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?
1 other identifier
interventional
183
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 8, 2012
CompletedFirst Posted
Study publicly available on registry
November 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 7, 2014
July 1, 2014
1.2 years
November 8, 2012
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative Vomiting
Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.
24 hr post-op
Study Arms (2)
Water
PLACEBO COMPARATORWater will be given as the study subject's first oral intake after emergence from general anesthesia.
Apple Juice
EXPERIMENTALApple juice will be given as the study subject's first oral intake after emergence from general anesthesia.
Interventions
Eligibility Criteria
You may qualify if:
- Dental surgery
- Tonsillectomy and adenoidectomy
- Strabismus surgery
- Age 2-18
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie R Wingate, MD
UNC Chapel Hill
- STUDY CHAIR
Peggy P McNaull, MD
UNC Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2012
First Posted
November 12, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
August 7, 2014
Record last verified: 2014-07