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

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ClinicalTrials.gov Identifier: NCT02421952
Recruitment Status : Completed
First Posted : April 21, 2015
Results First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mary Felberg, Baylor College of Medicine

Study Description
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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.

Condition or disease
Postoperative Nausea and Vomiting

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.

Study Design
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Study Type : Observational
Actual Enrollment : 208 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children
Study Start Date : April 2013
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : September 7, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Single Cohort
All subjects will be asked to assess their pain and nausea using the visual analogue scales (VAS), the modified faces scale and the BARF scale as described below in the preoperative and postoperative areas.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) [ Time Frame: When awake and responding to commands in the post-anesthesia 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).


Secondary Outcome Measures :
  1. Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary [ Time Frame: First 24 postoperative hours ]
    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).

  2. Age-Related Ability to Use the BARF Scale [ Time Frame: Comprehensive ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pre-operative patients at Texas Children's Hospital
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421952


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Mary Felberg, MD Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Mary Felberg, Baylor College of Medicine:
Study Protocol and Statistical Analysis Plan  [PDF] September 7, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mary Felberg, Pediatric Anesthesiologist, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02421952    
Other Study ID Numbers: H32386
First Posted: April 21, 2015    Key Record Dates
Results First Posted: March 30, 2020
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
 Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes