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Pain assessment remains difficult in children with cognitive impairment (CI). In this study, we evaluated the validity and reliability of the Face, Legs, Activity, Cry, Consolability (FLACC) tool for assessing pain in children with CI. Each child's developmental level and ability to self-report pain were evaluated. The child's nurse observed and scored pain with the FLACC tool before and after analgesic administration. Simultaneously, parents scored pain with a visual analog scale, and scores were obtained from children who were able to self-report pain. Observations were videotaped and later viewed by nurses blinded to analgesics and pain scores. One-hundred-forty observations were recorded from 79 children. FLACC scores correlated with parent scores (P < 0.001) and decreased after analgesics (P = 0.001), suggesting good validity. Correlations of total scores (r = 0.5-0.8; P < 0.001) and of each category (r = 0.3-0.8; P < 0.001), as well as measures of exact agreement (kappa = 0.2-0.65), suggest good reliability. Test-retest reliability was supported by excellent correlations (r = 0.8-0.883; P < 0.001) and categorical agreement (r = 0.617-0.935; kappa = 0.400-0.881; P < 0.001). These data suggest that the FLACC tool may be useful as an objective measure of postoperative pain in children with CI.The FLACC pain assessment tool may facilitate reliable and valid observational pain assessment in children with cognitive impairment who cannot self-report their pain. Objective pain assessment is important to facilitate effective postoperative pain management in these vulnerable children.