Aims and objectives: To evaluate the concurrent validity and reliability of the behavioural COMFORT and a modified version of the FLACC scale for assessment of pain and sedation in intubated and ventilated children and to evaluate the construct validity of the FLACC scale for assessment of pain.
Background: Few instruments are available for assessment of pain/sedation in paediatric intensive care.
Design: A prospective observational study was performed postoperatively in 40 children aged 0-10 years.
Methods: Two trained nurses observed the child simultaneously and assessing COMFORT behavioural (COMFORT-B) and FLACC scores. In comparison, two bedside nurses concurrently scored pain using an observational visual analogue scale (VAS(obs)) and sedation using the Nurse Interpretation of Sedation (NIS) score: oversedated, adequately or insufficient sedated. In 20 additional patients, one nurse assessed FLACC scores before and after analgesics.
Results: The majority of patients were <1 year. A moderate but significant correlation was found between each scale and both sedation and VAS(obs). COMFORT-B differentiated better than FLACC between the three sedation levels. For those assessed to be in pain (VAS(obs) > 3), both COMFORT-B and FLACC scores were significantly different compared with VAS(obs) < 3. The interrater reliability was high for COMFORT-B and FLACC (kappa 0.71 and 0.63, respectively). For bedside nurses' assessment of pain, the interrater reliability was high (kappa 0.63) but low for the level of sedation (kappa 0.20). After administration of analgesics, the FLACC median score decreased significantly from 5 to 0.
Conclusions: The COMFORT-B scale was a more reliable measure of children's sedation than bedside subjective assessment and gives more substantial information about sedation than the FLACC scale. Concurrent validity for assessment of pain was supported for both scales. The modified FLACC showed construct validity for measuring pain.
Relevance to clinical practice: The use of validated scales may improve the assessment and management of pain and sedation in intubated children.