Clinical trial NCT02421952: Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children
Official title: Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 208
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pre-operative patients at Texas Children's Hospital

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. 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.

Detailed description: 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. 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 3 years but below 18 years
2. Elective surgery
3. American Society of Anesthesiologists physical status 1-3 (Free from major concurrent disorders)
4. Free from nausea and / or vomiting in the previous 24 hours
5. Cognitive, visual, hearing and communicative ability to use the VAS as shown by the ability to complete a seriation task in which children pick the biggest of 6 cut out shapes, then the smallest, and the biggest remaining until no shapes remain (Beyer et al: J Pediatr Nurs 1992; 7: 335-46)

Exclusion Criteria:

1. Developmental delay
2. Blindness
3. Impaired cognitive or communicative abilities including inability to rate the intensity of symptoms and failure to complete the seriation task
4. Surgical procedures which may result in diminished hearing or vision in the immediate postoperative period
5. Nausea and /or vomiting within 24 hours prior to the procedure
6. Inability to understand English,
7. Patient or parental refusal to participate
8. Pregnant females

Primary outcomes:
measure: Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU)
timeFrame: When awake and responding to commands in the post-anesthesia care unit (PACU)
Secondary outcomes:
measure: Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary
timeFrame: First 24 postoperative hours
measure: Age-Related Ability to Use the BARF Scale
timeFrame: Comprehensive
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Mary Felberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watcha MF, Lee AD, Medellin E, Felberg MT, Bidani SA. Clinical Use of the Pictorial Baxter Retching Faces Scale for the Measurement of Postoperative Nausea in Children. Anesth Analg. 2019 Jun;128(6):1249-1255. doi: 10.1213/ANE.0000000000003850.