Trial Outcomes & Findings for Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in Children Who Speak Spanish (NCT NCT02007109)

Results Overview

Subjects rated their pain and nausea at these time points: (1) upon waking in the PACU, (2) just before and (3) 30-60 mins after receiving analgesic or antiemetic therapy, and (4) upon discharge from PACU. Scales range from 0 to 10 (lower scores indicate no pain or nausea).

Recruitment status

COMPLETED

Target enrollment

193 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	Nausea Measurement by VAS and BARF All patients will be asked to rate their nausea on both the VAS and the BARF scales. 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. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the 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?
Overall Study STARTED	193
Overall Study PACU Analysis	184
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	111

Reasons for withdrawal

Reasons for withdrawal
Measure	Nausea Measurement by VAS and BARF All patients will be asked to rate their nausea on both the VAS and the BARF scales. 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. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the 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?
Overall Study Diary not returned or excluded	102
Overall Study Excluded - Age<7yo	9

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nausea Measurement by VAS and BARF n=184 Participants All patients will be asked to rate their nausea on both the VAS and the BARF scales. 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. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the 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?
Age, Customized Age	10.9 years STANDARD_DEVIATION 3 • n=184 Participants
Sex: Female, Male Female	74 Participants n=184 Participants
Sex: Female, Male Male	110 Participants n=184 Participants
Region of Enrollment United States	184 participants n=184 Participants
Preoperative VAS Nausea (Normalized Values)	0.2 cm n=184 Participants
Preoperative VAS Pain (Normalized Values)	0.4 cm n=184 Participants
Preoperative FACES Pain	0.4 units on a scale n=184 Participants
Preoperative FACES Nausea	0.3 units on a scale n=184 Participants

PRIMARY outcome

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

Population: Some PACU data is partial due to subjects being uncooperative at times (n=5) or being asleep until just before discharge (n=2)

Subjects rated their pain and nausea at these time points: (1) upon waking in the PACU, (2) just before and (3) 30-60 mins after receiving analgesic or antiemetic therapy, and (4) upon discharge from PACU. Scales range from 0 to 10 (lower scores indicate no pain or nausea).

Outcome measures

Outcome measures
Measure	PACU Time n=177 Participants Subject's rated their pain and nausea while in PACU	Discharge From PACU n=175 Participants Subjects rated their pain and nausea upon discharge from PACU
Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) VAS Nausea	0.6 units Interval 0.0 to 10.0	0.4 units Interval 0.0 to 7.6
Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) VAS Pain	2.7 units Interval 0.0 to 10.0	1.3 units Interval 0.0 to 9.0
Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) FACES Nausea	0.9 units Interval 0.0 to 10.0	0.5 units Interval 0.0 to 8.0
Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) FACES Pain	2.7 units Interval 0.0 to 10.0	1.6 units Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: First 24 postoperative hours

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. 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.

Outcome measures

Outcome measures
Measure	PACU Time n=82 Participants Subject's rated their pain and nausea while in PACU	Discharge From PACU Subjects rated their pain and nausea upon discharge from PACU
Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV)	10 Participants	—

SECONDARY outcome

Timeframe: Time in the PACU

Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU

Outcome measures

Outcome measures
Measure	PACU Time n=184 Participants Subject's rated their pain and nausea while in PACU	Discharge From PACU Subjects rated their pain and nausea upon discharge from PACU
Pain and/or Nausea/Vomiting Rescue Needed	100 Participants	—

Adverse Events

Nausea Measurement by VAS and BARF

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