Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in Children Who Speak Spanish
Conditions: Postoperative Nausea and Vomiting
Sponsor: Baylor College of Medicine

COVER PAGE
Title: Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in
Children Who Speak Spanish
Principal Investigator: Mary Felberg, M.D.
NCT: NCT02007109
Institutional Protocol Number: H-32424
Institutional Initial Submit Date: 22 January 2013
Institutional Initial Approval Date: 7 June 2013
Institutional Closure Date: 7 September 2018

Human Protocol Report 
Page 1 of 11 
 
Institutional Review Board for Baylor College of Medicine and 
Affiliated Hospitals 
Protocol Number: H-32424 
Status: 
Closed 
Initial Submit Date: 1/22/2013 
Section Aa: Title & PI 
A1. Main Title 
USE OF BAXTER ANIMATED RETCHING FACES (BARF) SCALE TO MEASURE NAUSEA IN 
CHILDREN WHO SPEAK SPANISH 
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 CHALLMA N 
Phone: 832-824-5800 
Id: 
181593 
Fax: 
Email: 
karlsten@bcm.tmc.edu 
Mail Stn: BCM320 
Section Ab: General Information 
A4. Co-Investigators 
Name: 
EDUA RDO 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: 832-824-5319 
Id: 
193093 
Fax: 
Department: TCH ANESTHESIOLOGY 
Email: 
ow ensstu@bcm.tmc.edu 
Center: 
Mail Stn: BCM320 
Name: 
ANDREW DONG-GUN LEE 
Phone: 832-822-0761 
Id: 
194763 
Fax: 
Department: TCH ANESTHESIOLOGY 
Email: 
adlee@bcm.tmc.edu 
Center: 
Mail Stn: BCM320 
A5. Funding Source: 
Baylor College of Medicine (Internal Funding Only) 
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 2 of 11 
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 show n to be reliable in young children. A scale is a series of points made on a line that 
w ill be used for measurement; a mark on the far left of the line show s liitle pain and the mark on the far right 
means alot of pain. By default the most common objective outcome measure used in pediatric studies has 
been the incidence and number of emetic episodes. This measure, how ever, correlates poorly w ith the somatic 
subjective symptom of nausea. Apfel et al have show n that 30-40% of adult patients undergoing surgery have 
post discharge nausea and / or vomiting w hile 12% have vomiting. These data on nausea in adults w ere 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 know n 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 show n to have construct, content and convergent validity as an instrument to 
measure nausea in children. This w as a tw o center study that w as limited to chidlren w ho could speak English. 
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 low est age w here it can be used reliably, the score 
associated w ith a patient's perception of a need for treatment, the minimum change in the scores of clinical 
relevance and the test-retest reliability w hen nausea is rated as not having changed. The score has also not 
been validated in children w ho speak Spanish. This study is designed to provide the missing information and 
w ill specifically look at the Spanish speaking population. 
Section D: Purpose and Objectives 
This study in the pediatric Spanish speaking patient population is designed to determine: (1 ) The validity of the 
scale to measure nausea in Spanish speaking children (2) the incidence of postoperative nausea as compared 
to postoperative vomiting in the Post Anesthetic Care Unit (PACU) and on discharge (Post Discharge nausea 
and Vomiting) in this population (3) The minimal clinically relevant differences in nausea on 

https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 3 of 11 
the BARF and VAS scales. (4) The BARF and VAS scores associated w ith a patient?s perception of the need 
for treatment. (5) The test - retest reliability of the VAS and BARF scores w hen 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: 
Spanish 
Groups to be recruited w ill include: 
Patients 
Which if any of the follow ing vulnerable populations w ill be recruited as subjects? 
Children 
Vulnerable populations require special protections. How  w ill you obtain inf ormed consent, protect subject 
confidentiality, and prevent undue coercion? 
Potental subjects w ill 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 w ill 
be approached by study staff in the w aiting area prior to surgery. After the study is verbally explained, a 
w ritten consent form w ill be provided and time given to allow  consideration of study enrollment. The 
consent process w ill be conducted w ith emphasis on the voluntary nature of participation and that there is 
no direct benefit from enrollment. If the parents agree, a signed consent w ill be obtained along w ith a 
w ritten assent from the child w hen age appropriate. 
All research data w ill be kept secured and locked up in the office of the research co-ordinator. This office is 
located inside the office of the Department of Anesthesiology at Texas Children?s Hospital. This office is only 
accessible by a personal digital access cards. Unauthorized individuals w ould not be able to enter these 
facilities. Any electronic data w ill be kept in passw ord protected computers at the Texas Children's hospital, 
Department of Anesthesiology. The likelihood of such events is minimal. 
E3. Pregnant woman/fetus 
Will pregnant w omen 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 

https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 4 of 11 
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  
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 Spanish speaking patients undergoing surgery. There w ill be 
no group assignment, no placebo group and each patient w ill be his or her ow n control. Patients w ill 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 w ill occur solely for the purpose of the 
study. All patients w ill 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. 
How ever, the order in w hich the scales are presented to the patient for assessment w ill be randomized to 
reduce the potential for an order effect w here the patient choice of a response on one scale may influence 
the response on other scales. For example, having chosen a response tw o-thirds of the w ay up one scale, 
there w ill be a tendency to choose a response tw o-thirds of the w ay up the next scale. 
Inclusion Criteria: 
(1) Spanish speaking children (2) Age > 7 years but below  18 years (3) Elective surgery (4) A merican Society 
of Anesthesiologists physical status 1-3 (Free from major concurrent disorders) (5) Free from nausea and / or 
vomiting in the previous 24 hours (6) Cognitive and communicative ability to rate the intensity of symptoms as 
described below . 
Exclusion Criteria: 
(1) Inability to understand or speak Spanish (2) Developmental delay (3) Blindness (4) Impaired cognitive or 
communicative abilities including inability to rate the intensity of symptoms (5) Surgical procedure w here 
vision or hearing is anticipated to be impaired in the immediate postoperative period (6) Nausea and /or 
vomiting w ithin 24 hours of procedure, (7) Patient or parental refusal to participate (8) Pregnant females 
F2. Procedure 
The subject w ill be consented before further inclusion criteria is determined. We w ill determine if the child 
speaks Spanish. We w ill then determine if the child qualifies for the study by show ing 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. The child w ill then be asked by a Spanish speaking investigator 
to rate the comparative severity of pain in 3 vignettes -(a) w hen the doctor is listening to the chest, (b) w hen 
the child scraped a knee on the playground and (c) w hen receiving an injection. If the child can perform the 
tasks he / she w ill be considered to have qualified for the study. If they and the guardian agree to participate, 
w e w ill obtain baseline values as described below . 
Baseline Values: Baseline assessments of nausea before the procedure w ould be obtained from the aw ake 
child using both the visual analogue scale and the BARF scale. The order in w hich the first scale is presented 
to the patient for assessment w ill be randomized to reduce the potential for an order effect. The script for the 
scales w ould be standardized in keeping previous studies and w ould be a Spanish translation of the 
previously used English script. For the nausea scales, the script w ould be: ?Have you throw n up or felt like 
you w ere 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 ? For the Faces Scale, 
the script w ould be: ?These faces show  children w ho feel no nausea at all, w ho feel a little bit nauseous, w ho 
feel even more nauseous, and these are children w ho have a lot of nausea.? (Point to the each face at the 
appropriate time). Which face is more like you right now ?? The evaluator w ill assess if the child has 
understood the instructions and has the ability to provide a reliable response. 
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 5 of 11 
Intraoperative Care After providing baseline values in the preoperative holding area, the patient's anxiety 
w ould be assessed using the validated modified Yale Preoperative Anxiety scale (mYPAS) [see attachment], 
w hile the child is in the holding area, at the time of separation and w hen the face mask is applied during 
induction of anesthesia. The child w ould receive general anesthesia. The choice of drugs, techniques and 
perioperative management, including the need (if any) for preoperative medication, w ill be determined by the 
Attending Anesthesiologist according to the clinical needs and w ill not be changed for the purposes of the 
study. The patient w ill be monitored in keeping w ith the standards and policies of the department of 
Anesthesiology, Texas Children's Hospital. We w ill record these drugs, techniques and perioperative 
management. 
Postoperative Care: In the Post Anesthetic Care Unit (PACU) patients w ill 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 aw ake, the patients w ill be asked to rate their pain and nausea on both 
scales (VAS and FPS for pain, VAS and BARF for nausea). The order of presentation of scales w ill be the 
same as in the preoperative area. If a child receives analgesic or antiemetic therapy, he/she w ill be asked to 
rate the pain and nausea immediately before receiving the drug and 30-60 minutes after receiving 
treatment. In summary, patients w ill rate their pain and nausea using the VAS and the FPS-R for pain and 
the VAS and BARF scales for nausea at these time points: (1) before induction of anesthesia, (2) w hen 
aw ake in the PACU, (3) just before and (4) 30-60 mins after receiving analgesic or antiemetic therapy. The 
order of presentation of scales w ill be randomized but the same for all time points for an individual subject. 
After the first assessments are done in the PACU, patients w ill also be asked to rate their nausea on a 5 
point Likert scale as: (1) Much w orse than before, (2) A little w orse than before, (3) The same as before (4) 
A little better than before and (5) Much better than before. They w ill also be asked if they w ant any 
treatment of their nausea. Another set of assessments w ill be done just prior to discharge. All other aspects 
of patient management w ill be the standard care given to such children at the Texas Children?s Hospital. 
Patients w ill be discharged from the PACU w hen they have achieved the standard criteria set for discharge 
at the TCH. At the time of discharge w e w ill 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 w ill phone them about 24 hours after 
surgery and ask if the child had any nausea, vomiting and w hat medications w ere used after going home. 
We w ill ask the parent to rate their satisfaction w ith the control of nausea and w ith the entire perioperative 
experience on a 010 scale.We w ill remind them to mail the nausea assessments back and to state w hich 
face represented the maximum nausea after discharge. 
Section G: Sample Size/Data Analysis 
G1. Sample Size 
How  many subjects (or specimens, or charts) w ill be used in this study? 
Local: 240 
Worldw ide: 240 
Please indicate w hy you chose the sample size proposed: 
The pow er analysis w as calculated conservatively for the follow ing hypotheses: 
Hypothesis 1: Nausea scores on the BARF and VAS scales w ould be low er in children after the administration 
of an antiemetic. A reduction in the VAS by 2 cms and by 1 face on a faces scale is considered a clinically 
important reduction in symptoms.(13) Assuming that the SD of nausea on the VAS scale in children is similar to 
that in adults (2.5 cm) (14), a sample size of 27 w ould have a 90% pow er at the 0.01 level of significance in 
detecting a 2.0 cm difference in the VAS follow ing antiemetic therapy. Hypothesis 2: Children w ho received 
rescue antiemetics in the postoperative period w ill have higher postoperative nausea scores on the BARF and 
VAS scales than those w ho did not receive rescue antiemetics. In addition, children w ho required rescue 
antiemetics w ill have higher nausea scores at the time they received the rescue drug in the postoperative 
period than before they developed nausea. In other w ords, nausea scores in the postoperative period w ill be 
higher than scores prior to induction of anesthesia in children w ho received rescue antiemetics. (12) The pow er 
analysis for hypothesis 2 is similar to that for hypothesis 1, and a sample size of 27 w ould have a 90% pow er at 
the 0.01 level of significance in detecting a 2.0 cm difference in the VAS. 
Hypothesis 3: There w ill be a good correlation betw een the BARF and VAS scores for nausea. A sample size 
of 127 w ould be estimated for an estimated maximum r of 0.8, a half-w idth of the confidence interval of ? 0.1 
at an alpha of 0.01. (15) These estimates of r are in keeping w ith previous studies of the correlation betw een 

https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 6 of 11 
pain scores on the VAS and the FPS-R scales. (6) 
Allow ing for a 10% rate of dropouts and incomplete data,w e plan to recruit 240 patients in the preoperative 
area for the study to obtain data to test all hypotheses. 
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  w ill the analyses proposed relate to the primary purposes of your study? 
Visual analogue scores for pain and for nausea,and FPS-R scores for pain and BARF scores for nausea w ill be 
examined for normal distribution by the Kolmogorov-Smirnoff test,but it is anticipated that the distribution w ill not 
be normal. Descriptive statistics (mean,median,standard deviation,and frequency distribution) of the nausea 
and pain scores w ill be obtained. The incidence of postdischarge nausea w ill be determined from the responses 
recorded in the diary and in the follow  up phone call. The construct validity of the BARF scale w ould be 
assessed using the assumption that antiemetics reduce nausea and therefore nausea scores w ould be low er in 
children after the administration of an antiemetic (hypothesis 1). A subgroup of patients w ho received rescue 
antiemetics in the PACU w ill be examined. The pretreatment and post treatment VAS scores for nausea and 
BARF scores w ill be compared using a Wilcoxon test for non Gaussian distributed data. A reduction of scores 
by 2 cm on the VAS scale for nausea is traditionally accepted as a clinically satisfactory therapeutic response. 
A significant reduction in the BARF scores by 1 face in such patients w ill be accepted as construct validation. 
Content validity w ould be assessed by testing the hypothesis is that children w ith nausea w ill score higher on 
these scales than children w ithout nausea (hypothesis 2). We w ill compare the postoperative nausea scores in 
patients w ho received rescue antiemetic therapy w ith the scores in patients w ho did not require this therapy 
using the Mann Whitney test. In addition,w e w ill compare preoperative and postoperative BARF and VAS 
scores for nausea in patients w ho received antiemetics,making the assumption that healthy children w ill be free 
from nausea in the preoperative area. The Wilcoxon test for non Gaussian distributed data w ill be used for this 
comparison. Convergent validity w ould be tested by examining the correlation betw een BARF and VAS scales 
for nausea using the Spearman?s Rho test. The hypothesis tested is that there w ould be a good correlation 
betw een the tw o scales (hypothesis 3). Discriminant validity w ould be tested by examining the relationship 
betw een pain and nausea. The hypothesis tested is that there w ould be a poor correlation betw een pain and 
nausea scores,particularly after the administration of opioids for analgesia (hypothesis 4). The correlation 
betw een (1) VAS scores for pain and nausea and (2) pain scores using the FPS-R scale and nausea scores 
using the BARF scale w ill be determined. Discriminant validity w ould be accepted if the correlation betw een 
these scores is not as good as the correlation betw een (a) VAS score for pain and the FPS score,(b) VAS score 
for nausea and the BARF score. A subgroup of patients w ho received analgesic therapy in the PACU w ill be 
examined. The correlation betw een the change in pain scores and nausea scores w ith analgesic treatment w ill 
be examined using the Spearman?s Rho test. We can anticipate that there w ill be some correlations betw een 
nausea and pain as patients w ith pain often have concomitant nausea. How ever,satisfactory treatment of pain 
w ith opioids may not reduce nausea but even increase it,as nausea is a side effect of such therapy. 
Similarly,the correlation betw een the change in pain scores and nausea scores w ith antiemetic treatment w ill be 
examined using the Spearman?s Rho test. The hypothesis tested w ill be accepted if the correlation of VAS and 
FPS-R scores w ill differ from the correlation betw een VAS scores for nausea and BARF scores. P values below  
0.05 w ill be considered statistically significant. The minimum clinically relevant change in BARF and VAS 
scores for nausea w ill be determined by calculating the change in scores for patients w ho rated their nausea to 
be a little better than before or a little w orse than before. Similarly,the scores at w hich a patient felt the need for 
rescue therapy w ould be determined in those subjects w ho responded positively to a question ?Do you w ant 
any treatment for your nausea?? This w ill provide the threshold score for patient perception of the need for 
rescue therapy. The first and subsequent scores obtained from subjects w ho rated their symptoms as ?no 
change from before? w ill be examined using an intra-class coefficient >0.7 as the criterion for test / retest 
reliability. 
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 study w ill not involve any changes in surgical or anesthetic management of the child. Previous studies of 
pain and nausea in the postoperative period have not show n that repeated questioning of the patient for these 
symptoms has resulted in increased self reporting of pain or nausea scores and increased rescue therapy. It 

https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 7 of 11 
is therefore unlikely that the use of the pain and nausea scales w ill result in unnecessary therapy. The 
potential risk of this study includes a breach in confidentiality. All research data w ill be kept secured and 
locked up in the office of the research co-ordinator. This office is located inside the office of the Department 
of Anesthesiology at Texas Children's Hospital. This office is only accessible by a personal digital access 
cards. Unauthorized individuals w ould not be able to enter these facilities. Any electronic data w ill be kept in 
passw ord protected netw ork controlled by the IT department at the Texas Children's Hospital,Department of 
Anesthesiology. Paper copies of data forms w ill be stored in a locked cabinet in the Pediatric Anesthesiology 
office. . Electronic files w ill be maintained on passw ord secured computers. Data w ill be coded.The likelihood 
of such events is minimal. 
Section I: Potential Benefits 
Describe potential benefit(s) to be gained by the individual subject as a result of participating in the planned 
w ork. 
Patients w ill not have any direct immediate benefits from participating in these studies 
Describe potential benefit(s) to society of the planned w ork. 
Determining the validity of a faces pain scale for Spanish speaking subjects w ill extend the ability of 
physisicans to use this instrument to rate the severity and need for treatment of subjective symptoms to this 
population rather than being limited to English speaking subjects. 
Do anticipated benefits outw eigh potential risks? Discuss the risk-to-benefit ratio. 
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 w aiver of consent and authorization? 
NA 
J1a. Waiver of requirement for written documentation of Consent 
Will this research require a w aiver of the requirement for w ritten documentation of informed consent? 
NA 
J2. Consent Procedures 
Who w ill recruit subjects for this study? 
PI 
PI's staff 
Describe how  research population w ill be identified,recruitment procedures,any w aiting period betw een 
informing the prospective participant and obtaining consent,steps taken to minimize the possibility of coercion or 
undue influence and consent procedures in detail. 
Potental subjects w ill be identified from the surgery schedule at Texas Children's Hospital that is routinely 
available to Pediatric Anesthesiology for the purposes of case assignment. The parents w ill be approached 
by study staff in the w aiting area prior to surgery and the study w ill be introduced and explained. After the 
study is verbally explained,a w ritten consent form w ill be provided and time given to allow  consideration of 
study enrollment. The consent process w ill be conducted w ith emphasis on the voluntary nature of 
participation and that there is no direct benefit from enrollment. If the parents agree a signed consent w ill be 
obtained along w ith a w ritten assent from the child w hen age appropriate. 
Are foreign language consent forms required for this protocol? 
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 8 of 11 
Yes 
Which of the follow ing w ays will you document informed consent in languages other than English? 
Short-Form consent documents 
J3. Privacy and Intrusiveness 
Will the research involve observation or intrusion in situations w here the subjects w ould normally have an 
expectation of privacy? 
Yes 
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 w ho 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: 
NA 
Demographic information (name,D.O.B.,age,gender,race,etc.): 
NA 
Full Social Security #: 
NA 
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 9 of 11 
Partial Social Security # (Last four digits): 
NA 
Billing or financial records: 
NA 
Photographs,videotapes,and/or audiotapes of you: 
NA 
Other: 
NA  
At w hat institution w ill the physical research data be kept? 
NA 
How  w ill such physical research data be secured? 
NA 
At w hat institution w ill the electronic research data be kept? 
NA 
Such electronic research data w ill be secured via BCM IT Services- provided secured netw ork storage of 
electronic research data (Non-Portable devices only): 
NA 
Such electronic research data w ill be secured via Other: 
NA 
Will there be anyone besides the PI,the study staff,the IRB and the sponsor,w ho w ill 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. 
As stated in previuos sections confidentiality w ill be maintained by storing PHI behind locked doors only  
accessible by the PI and research staff. All Eclectronic data w ill be maintained on a TCH secure computed 
passw ord protectedcomputers. 
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 w hich items subject's insurance (or subject) w ill be responsible (surgery, 
device,drugs,etc). If appropriate,discuss the availability of financial counseling. 
The subject w ill not be charged for any research related costs. Subject w ill be charged for drugs and 
services for patient care that w ould occur even if the subject did not participate in the study. All research 
related costs w ill be borne by the Department of Anesthesiology,Texas Children's Hospital 
If subjects w ill 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. 
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 10 of 11 
Dollar Amount: 
0 
Distribution Plan: 
Section M: Genetics 
How  w ould 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 follow ing 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,w ho w ill provide the education or 
counseling and under w hat conditions w ill it be provided? If there is the possibility that a family's pedigree w ill be 
presented or published,please describe how  you w ill 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 w hether 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 
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 

https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018 

Human Protocol Report 
Page 11 of 11 
Section Q. Consent Form(s) 
USE OF BAXTER ANIMATED RETCHING FACES (BARF) SCALE TO MEASURE NAUSEA IN CHILDREN 
WHO SPEAK SPANISH 
Section R: Advertisements 
None 
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=374392 
9/27/2018