N/A N=193

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

Postoperative Nausea and Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT02007109 ↗

Enrolled (actual)

193

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) — 0.6; 0.4; 2.7; 1.3 units

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU)	0.6; 0.4; 2.7; 1.3; 0.9; 0.5	—
SECONDARY Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV)	10	—
SECONDARY Pain and/or Nausea/Vomiting Rescue Needed	100	—

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.

Eligibility Criteria

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.

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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Data sourced from ClinicalTrials.gov (NCT02007109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.