Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children
Conditions: Postoperative Nausea and Vomiting
Sponsor: Baylor College of Medicine

COVER PAGE
Title: Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children
Principal Investigator: Mary Felberg, M.D.
NCT: NCT02421952
Institutional Protocol Number: H-32386
Institutional Initial Submit Date: 25 January 2013
Institutional Initial Approval Date: 15 March 2013
Institutional Closure Date: 7 September 2018

Institutional Review Board for Baylor College of Medicine and
Affiliated Hospitals
Protocol Number:
H-32386
Status:
Closed
Initial Submit Date: 1/25/2013
Section Aa: Title & PI
A1. Main Title
CLINICAL USE OF BAXTER ANIMATED RETCHING FACES (BARF) SCALE IN CHILDREN
A2. Principal Investigator
Name:
MARY FELBERG
Phone:
832-824-5800
Id:
671715
Fax:
Department:
ANESTHESIOLOGY: BCM
Email:
mfelberg@bcm.tmc.edu
Center:
Mail Stn:
BCM320
A3. Administrative Contact
Name:
MELISSA CHALLMAN
Phone:
832-826-5600
Id:
181593
Fax:
Email:
karlsten@bcm.tmc.edu
Mail Stn:
BCM320
Section Ab: General Information
A4. Co-Investigators
Name:
MEHERNOOR F. WATCHA
Phone:
832-824-5800
Id:
157663
Fax:
Department:
ANESTHESIOLOGY: BCM
Email:
watcha@bcm.tmc.edu
Center:
Mail Stn:
BCM320
Name:
EDUARDO MEDELLIN JR
Phone:
832-824-5866
Id:
174073
Fax:
Department:
ANESTHESIOLOGY: BCM
Email:
emedelli@bcm.tmc.edu
Center:
Mail Stn:
BCM320
Name:
MARGARET OWENS-STUBERFIELD
Phone:
832-824-5800
Id:
193093
Fax:
Department:
ANESTHESIOLOGY: BCM
Email:
owensstu@bcm.tmc.edu
Center:
Mail Stn:
BCM320
Name:
ANDREW DONG-GUN LEE
Phone:
832-822-0761
Id:
194763
Fax:
Department:
ANESTHESIOLOGY: BCM
Email:
adlee@bcm.tmc.edu
Page 1 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

Center:
Mail Stn:
BCM320
A5. Funding Source:
Baylor College of Medicine (Internal Funding Only)
A6a. Institution(s) where work will be performed:
TCH: Texas Children's Hospital
A6b. Research conducted outside of the United States:
Country:
Facility/Institution:
Contact/Investigator:
Phone Number:
If documentation of assurances has not been sent to the Office of Research, please explain:
A7. Research Category:
A8. Therapeutic Intent
Does this trial have therapeutic intent?
Not set yet
Section B: Exempt Request
B. Exempt From IRB Review
Not Applicable
Section C: Background Information
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.
Section D: Purpose and Objectives
This study in the pediatric patient population is designed to determine: (1 ) The incidence of postoperative
Page 2 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

nausea as compared to postoperative vomiting in the Post Anesthetic Care Unit (PACU) and on discharge
(Post Discharge nausea and Vomiting). (2) The age related differences in the reliability and usefulness of the
BARF and VAS scales for measuring nausea. (3) The minimal clinically relevant differences in nausea on the
BARF and VAS scales. (4) The BARF and VAS scores associated with a patient's perception of the need for
treatment. (5) The test - retest reliability of the VAS and BARF scores when nausea is rated as unchanged.
Section E: Protocol Risks/Subjects
E1. Risk Category
Category 1: Research not involving greater than minimum risk.
E2. Subjects
Gender:
Both
Age:
Adolescent (13-17 yrs), Child (3-12 yrs)
Ethnicity:
All Ethnicities
Primary Language:
English
Groups to be recruited will include:
Patients
Which if any of the following vulnerable populations will be recruited as subjects?
Children
Vulnerable populations require special protections. How will you obtain informed consent, protect subject
confidentiality, and prevent undue coercion?
These are described in section J.
E3. Pregnant woman/fetus
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the research?
No
E4. Neonates
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart B) be enrolled in
the research?
No
E5. Children
Will children be enrolled in the research?
Yes
Section F: Design/Procedure
F1. Design
Select one category that most adequately describes your research:
d) Questionnaire/survey/interview
Page 3 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

Discuss the research design including but not limited to such issues as: probability of group assignment,
potential for subject to be randomized to placebo group, use of control subjects, etc.
The study design is a cross sectional study of patients undergoing surgery. There will be no group
assignment, no placebo group and each patient will be his or her own control. Patients will receive
standardized care according to the Attending Anesthesiologist?s opinion of the clinical requirements for the
specific situation. No changes in clinical practice or care of patients will occur solely for the purpose of the
study. All patients will be asked to assess their pain and nausea using the visual analogue scales, the
modified faces scale and the BARF scale as described below in the preoperative and postoperative areas.
However, the order in which the scales are presented to the patient for assessment will be randomized to
reduce the potential for an order effect where the patient choice of a response on one scale may influence the
response on other scales. For example, having chosen a response two-thirds of the way up one scale, there
will be a tendency to choose a response two-thirds of the way up the next scale.
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
F2. Procedure
We will first determine if the child will qualify for the study by showing 6 cut out shapes of different sizes and
asking the child to first choose the largest size, then the smallest, then the largest remaining size until no
more shapes are left. If the child qualifies for the study and if they agree to participate, we will obtain baseline
values as described below. Baseline Values: Baseline assessments of nausea before the procedure would be
obtained from the awake child using both the visual analogue scale and the BARF scale. The order in which
the first scale is presented to the patient for assessment will be randomized to reduce the potential for an
order effect. The script for the scales would be standardized in keeping previous studies. For the nausea
scales, the script would be: ?Have you thrown up or felt like you were going to throw up before? How did your
tummy feel then? We call that feeling of being sick to the stomach as nausea. VAS Scale: On this line the far
left indicates ?No nausea? and the far right? Worst nausea ever.? Can you show me on this line how much
nausea you have right now? Faces Scale: ?These faces show children who feel no nausea at all, who feel a
little bit nauseous, who feel even more nauseous, and these are children who have a lot of nausea.? (Point to
the each face at the appropriate time). Which face is more like you right now?? The evaluator will assess if
the child has understood the instructions and has the ability to provide a reliable response.
Perioperative Care
After providing baseline values in the preoperative holding area, the patient's anxiety would be assessed
using the validated modified Yale Preoperative Anxiety scale (mYPAS) (12), while the child is in the holding
area, at the time of separation and when the face mask is applied during induction of anesthesia. The child
would receive general anesthesia. The choice of drugs, techniques and perioperative management, including
the need (if any) for preoperative medication, will be determined by the Attending Anesthesiologist according
to the clinical needs and will not be changed for the purposes of the study. The patient will be monitored in
keeping with the standards and policies of the department of Anesthesiology, Texas Children?s Hospital. All
Perioperative data will be collected via medical record review. In the Post Anesthetic Care Unit (PACU)
patients will receive standard care, including analgesic or antiemetic therapy as prescribed by the Attending
Anesthesiologist based on his opinion of the clinical needs of the situation. When awake, the patients will be
asked to rate their nausea on both scales (VAS and BARF for nausea). The order of presentation of scales
will be the same as in the preoperative area. If a child receives analgesic or antiemetic therapy, he/she will be
asked to rate the pain and nausea immediately before receiving the drug and 30-60 minutes after receiving
treatment. In summary, patients will rate their nausea using the VAS and BARF scales for nausea at these
Page 4 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

time points: (1) before induction of anesthesia, (2) when awake in the PACU, (3) just before, and (4) 30-60
mins after receiving analgesic or antiemetic therapy and (5) just before discharge home. The order of
presentation of scales will be randomized but the same for all time points for an individual subject. After the
first set of assessments are done in the PACU, patients will also be asked to rate their nausea on a 5 point
Likert scale as : (1) Much worse than before, (2) A little worse than before, (3) The same as before (4) A little
better than before and (5) Much better than before. They will also be asked if they want any treatment of their
nausea. Another set of assessments will be just prior to discharge. All other aspects of patient management
will be the standard care given to such children at the Texas Children?s Hospital. Patients will be discharged
from the PACU when they have achieved the standard criteria set for discharge at the TCH. At the time of
discharge we will give the parents a diary to record the the MAXIMUM nausea on the VAS and BARF scales
and mail it back in a stamped envelope. We will phone them about 24 hours after surgery and ask if the child
had any nausea, vomiting and what medications were used after going home. We will ask the parent to rate
their satisfaction with the control of nausea and with the entire perioperative experience on a 0-10 scale.We
will remind them to mail the nausea assessments back and to state which face represented the maximum
nausea after discharge.
Section G: Sample Size/Data Analysis
G1. Sample Size
How many subjects (or specimens, or charts) will be used in this study?
Local: 387
Worldwide: 387
Please indicate why you chose the sample size proposed:
The study has a number of aims and the power analysis is provided separately for each aim: (1) In order to
examine the age related ability to use the BARF scale we will recruit 28 subjects each in the ages of 3, 4, 5,
6 ,7, 8, 9,10,11,12 and >12 years years (28 X 11 = 308). Power analysis was based on an alpha of 0.05,
power of 80% and a large effect size (Cohen's d = 0.80) as it was assumed a large difference would be
needed for the results to have clinical utility (Pain 2011; 152: 1327-33). This suggested a group size of 24
would be needed. Allowing for a drop out rate of 20% we plan to recruit 28 in each of the 11 groups. (2)
Power analysis for minimum clinically relevant difference in BARF scores: A one face difference in the BARF
scale is the minimum difference that can be detected. A previous study showed that the mean BARF scores
in the postoperative period in children was 1.6 +/- 2.4 (Pediatrics. 2011 Jun;127(6):e1542-9) . In order to
detect a 1 face difference with 80% power at the 0.05 level of significance we will need 93 subjects who had a
change in their nausea scores. Assuming an incidence of postoperative nausea and vomiting (PONV) of 33%
(which is similar to previous data in children), a group size of 93 X3= 279 will be required to obtain 93 subjects
with a change in nausea scores. We plan to recruit 387 subjects to allow for a 35% dropout rate.
This sample size will have a >80% power for the other aims of the study (The BARF and VAS scores
associated with a patient?s perception of the need for treatment and the test - retest reliability of the VAS and
BARF scores when nausea is rated as unchanged.)
G2. Data Analysis
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. comparison of
means, comparison of proportions, regressions, analysis of variance). Which is the PRIMARY
comparison/analysis? How will the analyses proposed relate to the primary purposes of your study?
Statistical Analysis: (1) The mean and SD of all scores will be calculated along with their distribution. The
incidence of postoperative nausea and postoperative vomiting in the PACU and after discharge (post-
discharge nausea) will be calculated. The incidence of severe nausea (score>6 on the BARF scale) and
severe vomiting (3 or more episodes over 24 hours) will also be determined. (2) We will record the age of a
child and their ability to rate their nausea on the BARF and VAS scales to determine the minimum age where
a patient can reliably use the scale. (3) Changes in BARF and VAS nausea scores will be calculated for
subjects who report their nausea as a little worse than before or a little better than before, to determine the
minimum change in scores of clinical relevance. (4) The BARF score and its relationship to the request for
rescue antiemetics will be examined by a Spearman?s rank correlation. (5) The relationship between the first
and subsequent BARF and VAS nausea scores in patients who state their nausea is ?the same as before?
will be examined by a Spearman?s rank correlation and a Cronbach?s alpha calculation. This will provide the
test ? retest reliability.
Page 5 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

Section H: Potential Risks/Discomforts
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or other) and assess
the likelihood and seriousness of such risks:
The risks are limited to possible loss of confidentiality as there are no changes in surgical or anesthetic
management of the child other than obtaining data on estimating the degree of nausea. Loss of confidentiality
is unlikely in view of standard steps taken to avoid this.
Section I: Potential Benefits
Describe potential benefit(s) to be gained by the individual subject as a result of participating in the planned
work.
Subjects will not have any direct immediate benefits from participating in these studies.
.
Describe potential benefit(s) to society of the planned work.
Determining the clinical utility of a faces pain scale will facilitate treatment and research into this clinically
important realm of suffering for children of all ages. Future patients may benefit from having such a tool as it
will permit clinicians to measure the symptom severity and then treat such patients
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio.
In this study the clinical management of the subject will not be changed in any manner. All decisions will be
based on the clinical requirements of the child as judged by the Attending Anesthesiologist and would be the
same even if the child did not participate in the study. The minimal risks of loss of confidentiality data is
exceeded by the potential benefits to society by demonstrating the clinical utility of a validated tool for
measuring nausea in children.
Section J: Consent Procedures
J1. Waiver of Consent
Will any portion of this research require a waiver of consent and authorization?
NA
J1a. Waiver of requirement for written documentation of Consent
Will this research require a waiver of the requirement for written documentation of informed consent?
NA
J2. Consent Procedures
Who will recruit subjects for this study?
PI
PI's staff
Describe how research population will be identified, recruitment procedures, any waiting period between
informing the prospective participant and obtaining consent, steps taken to minimize the possibility of coercion or
Page 6 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

undue influence and consent procedures in detail.
Potental subjects will be identified from the surgery schedule at Texas Children's Hospital that is routinely
available to Pediatric Anesthesiology for the purposes of case assignment. Parents of potential subjects will
be approached by study staff in the waiting area prior to surgery. After the study is verbally explained, a
written consent form will be provided and time given to allow consideration of study enrollment. The consent
process will be conducted with emphasis on the voluntary nature of participation and that there is no direct
benefit from enrollment. If the parents agree a signed consent will be obtained along with a written assent
from the subject when age appropriate.
Are foreign language consent forms required for this protocol?
No
J3. Privacy and Intrusiveness
Will the research involve observation or intrusion in situations where the subjects would normally have an
expectation of privacy?
No
J4. Children
Will children be enrolled in the research?
Yes
J5. Neonates
Will non-viable neonates or neonates of uncertain viability be involved in research?
No
J6. Consent Capacity - Adults who lack capacity
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research?
No
J7. Prisoners
Will Prisoners be enrolled in the research?
No
Section K: Research Related Health Information and Confidentiality
Will research data include identifiable subject information?
NA
Information from health records such as diagnoses, progress notes, medications, lab or radiology findings, etc.
NA
Specific information concerning alcohol abuse:
NA
Specific information concerning drug abuse:
NA
Specific information concerning sickle cell anemia:
NA
Specific information concerning HIV:
NA
Specific information concerning psychiatry notes:
Page 7 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

NA
Demographic information (name, D.O.B., age, gender, race, etc.):
NA
Full Social Security #:
NA
Partial Social Security # (Last four digits):
NA
Billing or financial records:
NA
Photographs, videotapes, and/or audiotapes of you:
NA
Other:
NA
At what institution will the physical research data be kept?
NA
How will such physical research data be secured?
NA
At what institution will the electronic research data be kept?
NA
Such electronic research data will be secured via BCM IT Services- provided secured network storage of
electronic research data (Non-Portable devices only):
NA
Such electronic research data will be secured via Other:
NA
Will there be anyone besides the PI, the study staff, the IRB and the sponsor, who will have access to identifiable
research data?
NA
Please describe the methods of transmission of any research data (including PHI, sensitive, and non-sensitive
data) to sponsors and/or collaborators.
NA
Will you obtain a Certificate of Confidentiality for this study?
No
Please further discuss any potential confidentiality issues related to this study.
NA
Section L: Cost/Payment
Delineate clinical procedures from research procedures. Will subject's insurance (or subject) be responsible for
research related costs? If so state for which items subject's insurance (or subject) will be responsible (surgery,
device, drugs, etc). If appropriate, discuss the availability of financial counseling.
The subject will not be charged for any research related costs. Subject will be charged for drugs and services
for patient care that would occur even if the subject did not participate in the study. All research related costs
Page 8 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

will be borne by the Department of Anesthesiology, Texas Children's Hospital
If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this research project, please note
the total dollar amount (or dollar value amount) and distribution plan (one payment, pro-rated payment, paid
upon completion, etc) of the payment.
Dollar Amount:
0
Distribution Plan:
Section M: Genetics
How would you classify your genetic study?
Discuss the potential for psychological, social, and/or physical harm subsequent to participation in this research.
Please discuss, considering the following areas: risks to privacy, confidentiality, insurability, employability,
immigration status, paternity status, educational opportunities, or social stigma.
Will subjects be offered any type of genetic education or counseling, and if so, who will provide the education or
counseling and under what conditions will it be provided? If there is the possibility that a family's pedigree will be
presented or published, please describe how you will protect family member's confidentiality?
Section N: Sample Collection
None
Section O: Drug Studies
Does the research involve the use of ANY drug* or biologic? (*A drug is defined as any substance that is used to
elicit a pharmacologic or physiologic response whether it is for treatment or diagnostic purposes)
No
Does the research involve the use of ANY gene transfer agent for human gene transfer research?
No
O1. Current Drugs
Is this study placebo-controlled?
No
Will the research involve a radioactive drug that is not approved by the FDA?
No
Section P: Device Studies
Does this study need an IDE?
No
Page 9 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391

Regarding your device study, could potential harm to subjects be life-threatening?
No
Regarding your device study, could potential harm to subjects result in permanent impairment of a body
function?
No
Regarding your device study, could potential harm to subjects result in permanent damage to a body structure?
No
Section Q. Consent Form(s)
Clinical Utility of the BARF scale
Section R: Advertisements
None
Page 10 of 10
Human Protocol Report
9/27/2018
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374391