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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01725399
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Post-operative Vomiting Other: Apple Juice Other: Water

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?
Study Start Date : October 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Water
Water will be given as the study subject's first oral intake after emergence from general anesthesia.
Other: Water
Experimental: Apple Juice
Apple juice will be given as the study subject's first oral intake after emergence from general anesthesia.
Other: Apple Juice


Outcome Measures

Primary Outcome Measures :
  1. Post-operative Vomiting [ Time Frame: 24 hr post-op ]
    Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.


Eligibility Criteria

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725399


Locations
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Jamie R Wingate, MD UNC Chapel Hill
Study Chair: Peggy P McNaull, MD UNC Chapel Hill
More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01725399     History of Changes
Other Study ID Numbers: 12-1792
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: July 2014

Keywords provided by University of North Carolina, Chapel Hill:
post-operative vomiting

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea