Clinical trial NCT02007109: Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in Children Who Speak Spanish
Official title: Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in Children Who Speak Spanish
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 193
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Spanish Speaking patients undergoing surgery

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.

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

Primary outcomes:
measure: Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU)
timeFrame: When awake and responding to commands in the post-anesthesia care unit (PACU)
Secondary outcomes:
measure: Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV)
timeFrame: First 24 postoperative hours
measure: Pain and/or Nausea/Vomiting Rescue Needed
timeFrame: Time in the PACU
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children't Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Mary A Felberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.