N/A
N=208
Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children
Postoperative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT02421952 ↗Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) — 60; 13; 8; 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) |
60; 13; 8; 2; 16; 62 | — |
| SECONDARY Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary |
34; 15; 16; 3; 8; 39 | — |
| SECONDARY Age-Related Ability to Use the BARF Scale |
100; 0; 89.5; 70.6; 81.1; 82.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age > 3 years but below 18 years
- Elective surgery
- American Society of Anesthesiologists physical status 1-3 (Free from major concurrent disorders)
- Free from nausea and / or vomiting in the previous 24 hours
- 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
- Developmental delay
- Blindness
- Impaired cognitive or communicative abilities including inability to rate the intensity of symptoms and failure to complete the seriation task
- Surgical procedures which may result in diminished hearing or vision in the immediate postoperative period
- Nausea and /or vomiting within 24 hours prior to the procedure
- Inability to understand English,
- Patient or parental refusal to participate
- Pregnant females
Data sourced from ClinicalTrials.gov (NCT02421952). 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.