NCT02007109|CompletedResults
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Sponsor study identifier
observational
193
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 8, 2018
Actual (reported)Study Completion
September 7, 2018
Actual (reported)Pediatric research in the management of nausea has been limited by the absence of a reliable method to quantify the intensity of this subjective symptom. In adults, the visual analog scale (VAS) is an accurate tool, but this has not been shown to be reliable in young children. A scale is a series of points made on a line that will be used for measurement; a mark on the far left of the line shows little pain and the mark on the far right means alot of pain.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 7, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 5, 2013
Actual (reported)December 10, 2013
Actual (reported)January 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 8, 2018
Actual (reported)September 7, 2018
Actual (reported)March 30, 2020
Actual (reported)Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU)
Subjects rated their pain and nausea at these time points: (1) upon waking in the PACU, (2) just before and (3) 30-60 mins after receiving analgesic or antiemetic therapy, and (4) upon discharge from PACU. Scales range from 0 to 10 (lower scores indicate no pain or nausea).
When awake and responding to commands in the post-anesthesia care unit (PACU)
Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV)
First 24 postoperative hours
Pain and/or Nausea/Vomiting Rescue Needed
Time in the PACU
All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: "Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the VAS scale: On this line the far left indicates "No nausea" and the far right" Worst nausea ever." Can you show me on this line how much nausea you have right now?
Spanish Speaking patients undergoing surgery
Texas Children't Hospital
Houston, Texas, 77030, United States
Watcha MF, Medellin E, Lee AD, Felberg MA, Bidani SA. Validation of the pictorial Baxter Retching Faces scale for the measurement of the severity of postoperative nausea in Spanish-speaking children. Br J Anaesth. 2018 Dec;121(6):1316-1322. doi: 10.1016/j.bja.2018.07.036. Epub 2018 Sep 7.
Mary A Felberg, MD
Baylor College of Medicine
193 participants (actual enrollment reported by the registry).
First Submitted
December 5, 2013
First Posted
December 10, 2013
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)
Contact the study team to confirm eligibility.
Primary Completion
March 8, 2018
Actual (reported)Study Completion
September 7, 2018
Actual (reported)Last Updated
March 30, 2020
Results First Posted
March 30, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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