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

NCT ID: NCT02421952

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 208 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2018-09-07

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.

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mary Felberg

Pediatric Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Felberg, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

References

Watcha MF, Lee AD, Medellin E, Felberg MT, Bidani SA. Clinical Use of the Pictorial Baxter Retching Faces Scale for the Measurement of Postoperative Nausea in Children. Anesth Analg. 2019 Jun;128(6):1249-1255. doi: 10.1213/ANE.0000000000003850.

Reference Type: DERIVED

PMID: 31094795 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H32386

Identifier Type: -

Identifier Source: org_study_id