Validation of the Pediatric Sedation State Scale.

OBJECTIVES: Development and validation of the Pediatric Sedation State Scale (PSSS) is intended to specifically meet the needs of pediatric procedural sedation providers to measure effectiveness and quality of care.

METHODS: The PSSS content was developed through Delphi methods utilizing leading pediatric sedation experts and published guidelines on procedural sedation in children. Video clips were created and presented to study participants, who graded the state of patients during procedures by using the PSSS to evaluate inter- and intrarater reliability by determining the intraclass correlation coefficient. We also compared the PSSS to the Observational Scale of Behavioral Distress-revised during 4 clinically relevant phases of a laceration repair procedure.

RESULTS: Six sedation states were defined for the PSSS. Each state was assigned a numerical value with higher numbers for increasing activity states. We included behaviors associated with adequate and inadequate sedation and adverse events associated with excessive sedation. Analysis of interrater and intrarater reliability revealed an intraclass correlation coefficient of 0.994 (95% confidence interval: 0.986-0.998) and 0.986 (95% confidence interval: 0.970-0.995), respectively. Criterion validity was confirmed with respect to the Observational Scale of Behavioral Distress-revised (Spearman r = 0.96). Construct validity was indicated by significant differences in PSSS scores ( P < .001) between 4 phases of a procedure, each having a different degree of painful or distressing stimuli.

CONCLUSIONS: The PSSS is a 6-point scale that is a valid measure of the effectiveness and quality of procedural sedation in children within the limits of the testing method used in this study.