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

Primary Purpose

Post-operative Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apple Juice
Water
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Vomiting focused on measuring post-operative vomiting

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • UNC Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Water

Apple Juice

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 8, 2012
Last Updated
August 5, 2014
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01725399
Brief Title
Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?
Acronym
XOndansetron
Official Title
Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Vomiting
Keywords
post-operative vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
Water will be given as the study subject's first oral intake after emergence from general anesthesia.
Arm Title
Apple Juice
Arm Type
Experimental
Arm Description
Apple juice will be given as the study subject's first oral intake after emergence from general anesthesia.
Intervention Type
Other
Intervention Name(s)
Apple Juice
Intervention Type
Other
Intervention Name(s)
Water
Primary Outcome Measure Information:
Title
Post-operative Vomiting
Description
Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.
Time Frame
24 hr post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie R Wingate, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peggy P McNaull, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Study Chair
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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