Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children

Postoperative Nausea and Vomiting Clinical Trial

— BARF  

Official title:

Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421952
• Other study ID #: H32386
• Status: Completed
• Start date: April 2013
• Est. completion date: September 7, 2018

Study information

• Verified date: March 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: September 7, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Vomiting

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU)	To measure pain and nausea, subjects completed the VAS and two pictorial scales (Faces Pain Scale-Revised for pain and BARF for nausea). The VAS uses a horizontal 10cm line with the extremes of "no pain at all" and "worst pain imaginable". The subject marks on the line their pain rating. Higher points indicate more severe or intense pain. FACES scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more pain). The BARF scales has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).	When awake and responding to commands in the post-anesthesia care unit (PACU)
Secondary	Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary	Patients were discharged from the PACU when they achieved institutional discharge criteria. The parents were given a diary to record the maximum nausea on the VAS and BARF scales during the first 24 postoperative hours. Each child's caretaker was contacted by phone 24 hours after surgery to determine whether the child had any nausea or vomiting and which medications were given after discharge. The VAS uses a horizontal 10cm line with the extremes of "no pain at all" and "worst pain imaginable". The subject marks on the line their pain rating. Higher points indicate more severe or intense pain. FACES scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more pain). The BARF scales has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).	First 24 postoperative hours
Secondary	Age-Related Ability to Use the BARF Scale	The age-related ability to use the BARF scale was determined by constructing receiver operating characteristic (ROC) curves and calculating the area under the ROC curve and the 95% confidence interval (CI), along with sensitivity and specificity.	Comprehensive