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

This study is currently recruiting participants.
Verified July 2013 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01725399
First received: November 8, 2012
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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 Intervention
Post-operative Vomiting
Other: Apple Juice
Other: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, 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?

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Post-operative Vomiting [ Time Frame: 24 hr post-op ] [ Designated as safety issue: No ]
    Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.


Estimated Enrollment: 216
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725399

Contacts
Contact: Jamie R Wingate, MD 419-236-7480 jamierwingate@gmail.com

Locations
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Peggy McNaull, MD         
Sub-Investigator: Jamie R Wingate, MD         
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

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01725399     History of Changes
Other Study ID Numbers: 12-1792
Study First Received: November 8, 2012
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014