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. 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.
Detailed description
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.
Interventions
None listed
Sponsors
Baylor College of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* (1) Spanish speaking children (2) Age \> 7 years but below 18 years (3) Elective surgery (4) American Society of Anesthesiologists physical status 1-3 (Free from major concurrent disorders) (5) Free from nausea and / or vomiting in the previous 24 hours (6) Cognitive and communicative ability to rate the intensity of symptoms as described below.
Exclusion criteria
* (1) Inability to understand or speak Spanish (2) Developmental delay (3) Blindness (4) Impaired cognitive or communicative abilities including inability to rate the intensity of symptoms (5) Surgical procedure where vision or hearing is anticipated to be impaired in the immediate postoperative period (6) Nausea and /or vomiting within 24 hours of procedure, (7) Patient or parental refusal to participate (8) Pregnant females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | When awake and responding to commands in the post-anesthesia 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV) | 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. |
| Pain and/or Nausea/Vomiting Rescue Needed | Time in the PACU | Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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? | 184 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Diary not returned or excluded | 102 |
| Overall Study | Excluded - Age<7yo | 9 |
Baseline characteristics
| Characteristic | Nausea Measurement by VAS and BARF | — |
|---|---|---|
| Age, Customized Age | 10.9 years STANDARD_DEVIATION 3 | — |
| Preoperative FACES Nausea | 0.3 units on a scale | — |
| Preoperative FACES Pain | 0.4 units on a scale | — |
| Preoperative VAS Nausea (Normalized Values) | 0.2 cm | — |
| Preoperative VAS Pain (Normalized Values) | 0.4 cm | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 184 participants | — |
| Sex: Female, Male Female | 74 Participants | — |
| Sex: Female, Male Male | 110 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 193 |
| other Total, other adverse events | 0 / 193 |
| serious Total, serious adverse events | 0 / 193 |
Outcome results
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).
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PACU Time | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | VAS Nausea | 0.6 units |
| PACU Time | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | VAS Pain | 2.7 units |
| PACU Time | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | FACES Nausea | 0.9 units |
| PACU Time | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | FACES Pain | 2.7 units |
| Discharge From PACU | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | FACES Pain | 1.6 units |
| Discharge From PACU | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | VAS Nausea | 0.4 units |
| Discharge From PACU | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | FACES Nausea | 0.5 units |
| Discharge From PACU | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) | VAS Pain | 1.3 units |
Secondary
Pain and/or Nausea/Vomiting Rescue Needed
Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU
Time frame: Time in the PACU
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PACU Time | Pain and/or Nausea/Vomiting Rescue Needed | 100 Participants |
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.
Time frame: First 24 postoperative hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PACU Time | Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV) | 10 Participants |