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Background Few investigators have evaluated pain assessment tools in the critical care setting. Objective To evaluate the reliability and validity of the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale in assessing pain in critically ill adults and children unable to self-report pain. Methods Three nurses simultaneously, but independently, observed and scored pain behaviors twice in 29 critically ill adults and 8 children: before administration of an analgesic or during a painful procedure, and 15 to 30 minutes after the administration or procedure. Two nurses used the FLACC scale, the third used either the Checklist of Nonverbal Pain Indicators (for adults) or the COMFORT scale (for children). Results For 73 observations, FLACC scores correlated highly with the other 2 scores (ρ = 0.963 and 0.849, respectively)