Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children? (XOndansetron)
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?|
- Post-operative Vomiting [ Time Frame: 24 hr post-op ] [ Designated as safety issue: No ]Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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.
|Other: Apple Juice|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725399
|Contact: Jamie R Wingate, MDfirstname.lastname@example.org|
|United States, North Carolina|
|UNC Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator: Peggy McNaull, MD|
|Sub-Investigator: Jamie R Wingate, MD|
|Principal Investigator:||Jamie R Wingate, MD||UNC Chapel Hill|
|Study Chair:||Peggy P McNaull, MD||UNC Chapel Hill|