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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2013

Interventions

  • Other: Apple Juice
  • Other: Water

Arms, Groups and Cohorts

  • Placebo Comparator: Water
    • Water will be given as the study subject’s first oral intake after emergence from general anesthesia.
  • Experimental: Apple Juice
    • Apple juice will be given as the study subject’s first oral intake after emergence from general anesthesia.

Clinical Trial Outcome Measures

Primary Measures

  • Post-operative Vomiting
    • Time Frame: 24 hr post-op
    • Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jamie R Wingate, MD, Principal Investigator, UNC Chapel Hill
    • Peggy P McNaull, MD, Study Chair, UNC Chapel Hill

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