Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in Children Who Speak Spanish

Completed

• Conditions: Postoperative Nausea and Vomiting

• Registration Number: NCT02007109
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed Description

By default the most common objective outcome measure used in pediatric studies has been the incidence and number of emetic episodes. This measure, however, correlates poorly with the somatic subjective symptom of nausea. Apfel et al have shown that 30-40% of adult patients undergoing surgery have post discharge nausea and / or vomiting while 12% have vomiting. These data on nausea in adults were based on a visual analog scale for nausea. There are no data on the incidence of postoperative nausea in children since the severity of symptoms are difficult to measure as younger children are known to be unable to use the VAS reliably. Recently a pictorial scale for measuring nausea, the Baxter Animated Retching Faces (BARF) scale, has been developed and shown to have construct, content and convergent validity as an instrument to measure nausea in children. This was a two center study that was limited to children who could speak English. The clinical usefulness of this scale in determining the incidence of postoperative and post-discharge nausea in children has yet to be determined including the lowest age where it can be used reliably, the score associated with a patient's perception of a need for treatment, the minimum change in the scores of clinical relevance and the test-retest reliability when nausea is rated as not having changed. The score has also not been validated in children who speak Spanish. This study is designed to provide the missing information and will specifically look at the Spanish speaking population.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Study Start: 2014-01
• Primary Completion: 2018-03-08
• Study Completion: 2018-09-07
• Results First Submitted: 2018-10-04
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Results First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

• (1) Spanish speaking children (2) Age > 7 years but below 18 years (3) Elective surgery (4) American Society of Anesthesiologists physical status 1-3 (Free from major concurrent disorders) (5) Free from nausea and / or vomiting in the previous 24 hours (6) Cognitive and communicative ability to rate the intensity of symptoms as described below.

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Exclusion Criteria

• (1) Inability to understand or speak Spanish (2) Developmental delay (3) Blindness (4) Impaired cognitive or communicative abilities including inability to rate the intensity of symptoms (5) Surgical procedure where vision or hearing is anticipated to be impaired in the immediate postoperative period (6) Nausea and /or vomiting within 24 hours of procedure, (7) Patient or parental refusal to participate (8) Pregnant females

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU)	When awake and responding to commands in the post-anesthesia 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).

Secondary Outcome Measures

Name	Time	Method
Pain and/or Nausea/Vomiting Rescue Needed	Time in the PACU	Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU
Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV)	First 24 postoperative hours	The study design is a cross sectional study of patients undergoing surgery. There will be no group assignment, no placebo group and each patient will be his or her own control. All patients will be asked to assess their pain and nausea using the visual analogue scales, the modified faces scale and the BARF scale as described below in the preoperative and postoperative areas.

Trial Locations

Locations (1)

Texas Children't Hospital; 🇺🇸 Houston, Texas, United States