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

Post-operative Vomiting Clinical Trial

— XOndansetron  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725399
• Other study ID #: 12-1792
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: August 5, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Post-operative Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• Apple Juice

• Water

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Vomiting	Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.	24 hr post-op	No