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

NCT ID: NCT01725399

Last Updated: 2014-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-operative Vomiting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Water

Water will be given as the study subject's first oral intake after emergence from general anesthesia.

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

Apple Juice

Apple juice will be given as the study subject's first oral intake after emergence from general anesthesia.

Group Type EXPERIMENTAL

Apple Juice

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apple Juice

Intervention Type OTHER

Water

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jamie R Wingate, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Peggy P McNaull, MD

Role: STUDY_CHAIR

UNC Chapel Hill

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-1792

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.