The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment

Summary Background: Difficulty with pain assessment in individuals who cannot self‐report their pain poses a significant barrier to effective pain management. However, available assessment tools lack consistent reliability as pain measures in children with cognitive impairment (CI). This study evaluated the validity and reliability of the revised and individualized Face Legs Activity Cry and Consolability (FLACC) behavioral pain assessment tool in children with CI. Methods: Children with CI scheduled for elective surgery were studied. The FLACC was revised to include specific descriptors and parent‐identified, unique behaviors for individual children. The child's ability to self‐report pain was evaluated. Postoperatively, two nurses scored pain using the revised FLACC scale before and after analgesic administration, and, children self‐reported a pain score, if able. Observations were videotaped and later viewed by experienced nurses blinded to analgesic administration. Results: Eighty observations were recorded in 52 children aged 4–19 years. Twenty‐one parents added individualized pain behaviors to the revised FLACC. Interrater reliability was supported by excellent intraclass correlation coefficients (ICC, ranging from 0.76 to 0.90) and adequate κ statistics (0.44–0.57). Criterion validity was supported by the correlations between FLACC, parent, and child scores (ρ = 0.65–0.87; P