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OpenTrials
Completed

NCT Number: NCT01725399

Does First Oral Intake After Emergence 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.

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Key information

Conditions

Post-operative Vomiting

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apple juice

Other

Water

Other

Primary outcomes

  1. Post-operative Vomiting

    Time frame: 24 hr post-op

    Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: XOndansetron

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 12, 2012
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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