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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. 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic 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). | When awake and responding to commands in the post-anesthesia care unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Pre-operative patients at Texas Children's Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Mary Felberg, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31094795 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
208 subjects screened for the ability to use VAS and Pictorial Scales. 16 subjects excluded from PACU and Post-discharge analysis for failed seriation task, being uncooperative during baseline assessment, or having their surgery cancelled after consent was obtained.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic 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). | 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. | Posted | Count of Participants | Participants | When awake and responding to commands in the post-anesthesia care unit (PACU) |
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 | 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. |
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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 |
| Age-Related Ability to Use the BARF Scale | 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. | Comprehensive |
| Surgery cancelled |
|
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Could use BARF for all time points | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Single Cohort | 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. |
|
|
| Secondary | Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | 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). | Posted | Count of Participants | Participants | First 24 postoperative hours |
|
|
|
| Secondary | Age-Related Ability to Use the BARF Scale | 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. | All enrolled subjects were included. | Posted | Number | 95% Confidence Interval | percentage | Comprehensive |
|
|
|
| 0 |
| 208 |
| 0 |
| 208 |
| 0 |
| 208 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| Title | Measurements |
|---|---|
|
| Severe Emesis (>= 3 episodes) |
|
| Rescue Antiemetics |
|
| Post-Discharge Nausea OR Vomiting |
|
| Post-Discharge Nausea AND Vomiting |
|
| 5-5.9 years |
|
| 6-6.9 years |
|
| 7-7.9 years |
|
| 8-11.9 years |
|
| 12-17.9 years |
|