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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. A scale is a series of points made on a line that will be used for measurement; a mark on the far left of the line shows little 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, 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. This was a two center study that was limited to children who 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 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. The score has also not been validated in children who speak Spanish. This study is designed to provide the missing information and will specifically look at the Spanish speaking population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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? |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | 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). | When awake and responding to commands in the post-anesthesia care unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Spanish Speaking patients undergoing surgery
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| Name | Affiliation | Role |
|---|---|---|
| Mary A Felberg, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children't Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30442259 | Derived | Watcha MF, Medellin E, Lee AD, Felberg MA, Bidani SA. Validation of the pictorial Baxter Retching Faces scale for the measurement of the severity of postoperative nausea in Spanish-speaking children. Br J Anaesth. 2018 Dec;121(6):1316-1322. doi: 10.1016/j.bja.2018.07.036. Epub 2018 Sep 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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? |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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? |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | 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). | Some PACU data is partial due to subjects being uncooperative at times (n=5) or being asleep until just before discharge (n=2) | Posted | Mean | Full Range | units | When awake and responding to commands in the post-anesthesia care unit (PACU) |
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Subjects were monitored for adverse events while active in the study (from enrollment until diaries were completed at 24 hours PACU discharge).
This is a minimal risk, cross-sectional study of pain and nausea using three scales. There was no randomization or intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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? |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Felberg | Baylor College of Medicine | 832-824-5800 | mafelber@texaschildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2018 | Jan 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| First 24 postoperative hours |
| Pain and/or Nausea/Vomiting Rescue Needed | Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU | Time in the PACU |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Preoperative VAS Nausea (Normalized Values) | Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no nausea" and "worst nausea." | Mean | Full Range | cm |
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| Preoperative VAS Pain (Normalized Values) | Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." | Mean | Full Range | cm |
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| Preoperative FACES Pain | Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain." | Mean | Full Range | units on a scale |
|
| Preoperative FACES Nausea | Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No nausea" and "10" equals "Very much nausea." | Mean | Full Range | units on a scale |
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Subjects rated their pain and nausea upon discharge from PACU |
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| Secondary | Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV) | 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. | Posted | Count of Participants | Participants | First 24 postoperative hours |
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| Secondary | Pain and/or Nausea/Vomiting Rescue Needed | Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU | Posted | Count of Participants | Participants | Time in the PACU |
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| 0 |
| 193 |
| 0 |
| 193 |
| 0 |
| 193 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |