Houston, Texas 77030


Purpose:

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.


Study 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. 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.


Criteria:

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


NCT ID:

NCT02421952


Primary Contact:

Principal Investigator
Sudha A Bidani, MD
Baylor College of Medicine

Margarer A Owens-Stuberfield, RN
Phone: 832-824-5913
Email: owensstu@bcm.edu


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Sudha A Bidani, MD
Phone: 832-824-5800
Email: sbidani@bcm.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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