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

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02421952
• Collaborator: (none)
• Enrollment: 208
• Location: 1
• Duration (Months): 65.2
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• 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: Apr 1, 2013
• Actual Primary Completion Date: Mar 8, 2018
• Actual Study Completion Date: Sep 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

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) [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 [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 [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

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

• Principal Investigator: Mary Felberg, MD, Baylor College of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 7, 2018

More Information

Publications

None provided.

• Responsible Party: Mary Felberg, Pediatric Anesthesiologist, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02421952
• Other Study ID Numbers: H32386
• First Posted: Apr 21, 2015
• Last Update Posted: Mar 30, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Vomiting; Postoperative Nausea and Vomiting

Study Results

Participant Flow

Arm/Group Title	Single Cohort
Arm/Group Description	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.
Period Title: Overall Study
STARTED	208
Excluded From PACU and Post-Analysis	16
Included in PACU Analysis	192
COMPLETED	99
NOT COMPLETED	109

Baseline Characteristics

Arm/Group Title	Single Cohort
Arm/Group Description	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.
Overall Participants	208
Age, Customized (Count of Participants)
3-3.9 years	32 15.4%
4-4.9 years	18 8.7%
5-5.9 years	26 12.5%
6-6.9 years	18 8.7%
7-7.9 years	21 10.1%
8-11.9 years	71 34.1%
12-17.9 years	22 10.6%
Sex/Gender, Customized (Count of Participants)
Male	124 59.6%
Female	67 32.2%
Unknown	1 0.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	208 100%
Could use BARF for all time points (Count of Participants)
Count of Participants [Participants]	190 91.3%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU)
Description	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).
Time Frame	When awake and responding to commands in the post-anesthesia care unit (PACU)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Single Cohort
Arm/Group Description	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.
Measure Participants	192
Any Nausea	60 28.8%
Severe Nausea (Score >6)	13 6.3%
Any Emesis	8 3.8%
Severe Emesis (>= 3 episodes)	2 1%
Rescue Antiemetics	16 7.7%
Postoperative Nausea OR Vomiting	62 29.8%
Postoperative Nausea AND Vomiting	6 2.9%

2. Secondary Outcome

Title	Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary
Description	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).
Time Frame	First 24 postoperative hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Cohort
Arm/Group Description	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.
Measure Participants	99
Nausea	34 16.3%
Severe Nausea Score >6)	15 7.2%
Any Emesis	16 7.7%
Severe Emesis (>= 3 episodes)	3 1.4%
Rescue Antiemetics	8 3.8%
Post-Discharge Nausea OR Vomiting	39 18.8%
Post-Discharge Nausea AND Vomiting	11 5.3%

3. Secondary Outcome

Title	Age-Related Ability to Use the BARF Scale
Description	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.
Time Frame	Comprehensive

Outcome Measure Data

Analysis Population Description

All enrolled subjects were included.

Arm/Group Title	Sensitivity	Specificity
Arm/Group Description	ROC Curve Using Age as Cutoff Points	ROC Curve Using Age as Cutoff Points
Measure Participants	208	208
3-3.9 years	100	0
4-4.9 years	89.5	70.6
5-5.9 years	81.1	82.4
6-6.9 years	68.9	100
7-7.9 years	59.5	100
8-11.9 years	48.4	100
12-17.9 years	11.6	100

Adverse Events

Time Frame	Subjects were monitored for adverse events while active in the study (from enrollment until diaries were completed at 24 hours PACU discharge).
Adverse Event Reporting Description	This is a minimal risk, cross-sectional study of pain and nausea using three scales. There was no randomization or intervention.
Arm/Group Title	Single Cohort
Arm/Group Description	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.
All Cause Mortality
	Single Cohort
	Affected / at Risk (%)	# Events
Total	0/208 (0%)
Serious Adverse Events
	Single Cohort
	Affected / at Risk (%)	# Events
Total	0/208 (0%)
Other (Not Including Serious) Adverse Events
	Single Cohort
	Affected / at Risk (%)	# Events
Total	0/208 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.