Related Experiment Video
Updated: Jun 24, 2026
Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
The COMFORT behavioural scale and the modified FLACC scale in paediatric intensive care
Monica Johansson1, Eva Kokinsky
1Paediatric Intensive Care Unit, Queen Silvia Children's Hospital, Göteborg, Sweden. monica.rn.johansson@vgregion.se
Insights
This study validated the COMFORT Behavioural (COMFORT-B) and FLACC scales for assessing pain and sedation in intubated children. Both scales showed concurrent validity for pain, with COMFORT-B offering more reliable sedation assessment.
Area of Science:
- Pediatric critical care medicine
- Pain and sedation assessment tools
- Clinical validation studies
Background:
- Limited validated instruments exist for pain and sedation assessment in pediatric intensive care units (PICUs).
- Accurate assessment is crucial for effective management of intubated and ventilated children.
Purpose of the Study:
- To evaluate the concurrent validity and reliability of the COMFORT Behavioural (COMFORT-B) and a modified FLACC scale for pain and sedation in intubated children.
- To assess the construct validity of the FLACC scale for pain measurement.
Main Methods:
- Prospective observational study involving 40 intubated children (0-10 years).
- Two trained nurses simultaneously assessed COMFORT-B and FLACC scores.
- Bedside nurses concurrently used a visual analogue scale (VASobs) for pain and the Nurse Interpretation of Sedation (NIS) score.
- FLACC scores were assessed before and after analgesics in 20 additional patients.
Main Results:
- Moderate, significant correlations were found between scales and sedation/VASobs.
- COMFORT-B demonstrated superior differentiation of sedation levels compared to FLACC.
- Both scales showed significant differences for pain (VASobs > 3) versus no pain (VASobs < 3).
- High interrater reliability was observed for COMFORT-B (kappa 0.71) and FLACC (kappa 0.63) for pain assessment.
- FLACC scores significantly decreased after analgesic administration (median 5 to 0).
Conclusions:
- The COMFORT-B scale is a more reliable and informative measure of sedation in intubated children than subjective bedside assessment and the FLACC scale.
- Both COMFORT-B and FLACC scales demonstrated concurrent validity for pain assessment.
- The modified FLACC scale exhibited construct validity for pain measurement.
- Utilizing validated scales can enhance pain and sedation assessment and management in critically ill children.
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.
