Postoperative Nausea and Vomiting
Conditions
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.
Interventions
None listed
Sponsors
Baylor College of Medicine
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 208 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Diary Not Returned | 93 |
| Overall Study | Failed seriation task | 13 |
| Overall Study | Subject uncooperative for baseline test | 2 |
| Overall Study | Surgery cancelled | 1 |
Baseline characteristics
| Characteristic | Single Cohort | — |
|---|---|---|
| Age, Customized 12-17.9 years | 22 Participants | — |
| Age, Customized 3-3.9 years | 32 Participants | — |
| Age, Customized 4-4.9 years | 18 Participants | — |
| Age, Customized 5-5.9 years | 26 Participants | — |
| Age, Customized 6-6.9 years | 18 Participants | — |
| Age, Customized 7-7.9 years | 21 Participants | — |
| Age, Customized 8-11.9 years | 71 Participants | — |
| Could use BARF for all time points | 190 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 208 participants | — |
| Sex/Gender, Customized Female | 67 Participants | — |
| Sex/Gender, Customized Male | 124 Participants | — |
| Sex/Gender, Customized Unknown | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 208 |
| other Total, other adverse events | 0 / 208 |
| serious Total, serious adverse events | 0 / 208 |
Outcome results
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).
Time frame: When awake and responding to commands in the post-anesthesia care unit (PACU)
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Cohort | Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) | Postoperative Nausea OR Vomiting | 62 Participants |
| Single Cohort | Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) | Any Nausea | 60 Participants |
| Single Cohort | Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) | Severe Nausea (Score >6) | 13 Participants |
| Single Cohort | Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) | Any Emesis | 8 Participants |
| Single Cohort | Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) | Severe Emesis (>= 3 episodes) | 2 Participants |
| Single Cohort | Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) | Rescue Antiemetics | 16 Participants |
| Single Cohort | Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU) | Postoperative Nausea AND Vomiting | 6 Participants |
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.
Time frame: Comprehensive
Population: All enrolled subjects were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Cohort | Age-Related Ability to Use the BARF Scale | 5-5.9 years | 81.1 percentage |
| Single Cohort | Age-Related Ability to Use the BARF Scale | 7-7.9 years | 59.5 percentage |
| Single Cohort | Age-Related Ability to Use the BARF Scale | 4-4.9 years | 89.5 percentage |
| Single Cohort | Age-Related Ability to Use the BARF Scale | 8-11.9 years | 48.4 percentage |
| Single Cohort | Age-Related Ability to Use the BARF Scale | 6-6.9 years | 68.9 percentage |
| Single Cohort | Age-Related Ability to Use the BARF Scale | 12-17.9 years | 11.6 percentage |
| Single Cohort | Age-Related Ability to Use the BARF Scale | 3-3.9 years | 100 percentage |
| Specificity | Age-Related Ability to Use the BARF Scale | 12-17.9 years | 100 percentage |
| Specificity | Age-Related Ability to Use the BARF Scale | 3-3.9 years | 0 percentage |
| Specificity | Age-Related Ability to Use the BARF Scale | 4-4.9 years | 70.6 percentage |
| Specificity | Age-Related Ability to Use the BARF Scale | 5-5.9 years | 82.4 percentage |
| Specificity | Age-Related Ability to Use the BARF Scale | 6-6.9 years | 100 percentage |
| Specificity | Age-Related Ability to Use the BARF Scale | 7-7.9 years | 100 percentage |
| Specificity | Age-Related Ability to Use the BARF Scale | 8-11.9 years | 100 percentage |
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).
Time frame: First 24 postoperative hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Cohort | Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | Nausea | 34 Participants |
| Single Cohort | Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | Severe Nausea Score >6) | 15 Participants |
| Single Cohort | Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | Any Emesis | 16 Participants |
| Single Cohort | Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | Severe Emesis (>= 3 episodes) | 3 Participants |
| Single Cohort | Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | Rescue Antiemetics | 8 Participants |
| Single Cohort | Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | Post-Discharge Nausea OR Vomiting | 39 Participants |
| Single Cohort | Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary | Post-Discharge Nausea AND Vomiting | 11 Participants |