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?

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Vomiting
• Intervention / Treatment: Other: Water; Other: Apple Juice

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 8, 2012
• First Posted (Estimate): November 12, 2012

Study Record Updates

• Last Update Posted (Estimate): August 7, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: post-operative vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 12-1792