Trial Outcomes & Findings for Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children (NCT NCT02421952)

NCT ID: NCT02421952

Last Updated: 2020-03-30

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

208 participants

Primary outcome timeframe

When awake and responding to commands in the post-anesthesia care unit (PACU)

Results posted on

2020-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Single Cohort The study design is a cross sectional study of patients undergoing surgery. There was no group assignment, no placebo group and each subject was his or her own control. All patients were asked to assess their pain and nausea using the visual analogue scales (VAS), the modified faces scale, and the BARF scale in the preoperative and postoperative areas.
Overall Study STARTED	208
Overall Study Excluded From PACU and Post-Analysis	16
Overall Study Included in PACU Analysis	192
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	109

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Cohort The study design is a cross sectional study of patients undergoing surgery. There was no group assignment, no placebo group and each subject was his or her own control. All patients were asked to assess their pain and nausea using the visual analogue scales (VAS), the modified faces scale, and the BARF scale in the preoperative and postoperative areas.
Overall Study Diary Not Returned	93
Overall Study Failed seriation task	13
Overall Study Subject uncooperative for baseline test	2
Overall Study Surgery cancelled	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Cohort n=208 Participants 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.
Age, Customized 3-3.9 years	32 Participants n=208 Participants
Age, Customized 4-4.9 years	18 Participants n=208 Participants
Age, Customized 5-5.9 years	26 Participants n=208 Participants
Age, Customized 6-6.9 years	18 Participants n=208 Participants
Age, Customized 7-7.9 years	21 Participants n=208 Participants
Age, Customized 8-11.9 years	71 Participants n=208 Participants
Age, Customized 12-17.9 years	22 Participants n=208 Participants
Sex/Gender, Customized Male	124 Participants n=208 Participants
Sex/Gender, Customized Female	67 Participants n=208 Participants
Sex/Gender, Customized Unknown	1 Participants n=208 Participants
Region of Enrollment United States	208 participants n=208 Participants
Could use BARF for all time points	190 Participants n=208 Participants

PRIMARY outcome

Timeframe: When awake and responding to commands in the post-anesthesia care unit (PACU)

Population: Patients with severe nausea were included in the number with any nausea. Patients with severe emesis were included in the number with any emesis. Because some patients had both nausea and vomiting, the sum of the number with nausea and the number with emesis will not equal those with either nausea or emesis.

Outcome measures

Outcome measures
Measure	Single Cohort n=192 Participants Includes subjects who consented to participate, passed the seriation task, remained cooperative during the baseline assessment, and whose surgeries were not cancelled following informed consent.	Specificity ROC Curve Using Age as Cutoff Points
Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) Any Nausea	60 Participants	—
Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) Severe Nausea (Score >6)	13 Participants	—
Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) Any Emesis	8 Participants	—
Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) Severe Emesis (>= 3 episodes)	2 Participants	—
Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) Rescue Antiemetics	16 Participants	—
Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) Postoperative Nausea OR Vomiting	62 Participants	—
Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) Postoperative Nausea AND Vomiting	6 Participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Single Cohort n=99 Participants Includes subjects who consented to participate, passed the seriation task, remained cooperative during the baseline assessment, and whose surgeries were not cancelled following informed consent.	Specificity ROC Curve Using Age as Cutoff Points
Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary Nausea	34 Participants	—
Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary Severe Nausea Score >6)	15 Participants	—
Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary Any Emesis	16 Participants	—
Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary Severe Emesis (>= 3 episodes)	3 Participants	—
Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary Rescue Antiemetics	8 Participants	—
Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary Post-Discharge Nausea OR Vomiting	39 Participants	—
Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary Post-Discharge Nausea AND Vomiting	11 Participants	—

SECONDARY outcome

Timeframe: Comprehensive

Population: All enrolled subjects were included.

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.

Outcome measures

Outcome measures
Measure	Single Cohort n=208 Participants Includes subjects who consented to participate, passed the seriation task, remained cooperative during the baseline assessment, and whose surgeries were not cancelled following informed consent.	Specificity n=208 Participants ROC Curve Using Age as Cutoff Points
Age-Related Ability to Use the BARF Scale 5-5.9 years	81.1 percentage Interval 74.6 to 86.2	82.4 percentage Interval 55.8 to 95.3
Age-Related Ability to Use the BARF Scale 3-3.9 years	100 percentage Interval 97.5 to 100.0	0 percentage Interval 0.0 to 22.9
Age-Related Ability to Use the BARF Scale 4-4.9 years	89.5 percentage Interval 84.0 to 93.3	70.6 percentage Interval 44.0 to 88.6
Age-Related Ability to Use the BARF Scale 6-6.9 years	68.9 percentage Interval 61.8 to 75.3	100 percentage Interval 77.1 to 100.0
Age-Related Ability to Use the BARF Scale 7-7.9 years	59.5 percentage Interval 52.1 to 66.5	100 percentage Interval 77.1 to 100.0
Age-Related Ability to Use the BARF Scale 8-11.9 years	48.4 percentage Interval 41.2 to 55.7	100 percentage Interval 77.1 to 100.0
Age-Related Ability to Use the BARF Scale 12-17.9 years	11.6 percentage Interval 7.5 to 17.1	100 percentage Interval 77.1 to 100.0

Adverse Events

Single Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mary Felberg

Baylor College of Medicine

Phone: 832-824-5800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place