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Table 1 Definitions of the multiple outcomes included in this study protocol

From: Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial

Outcome Definition Instrument/tool
Children’s behavior toward dental treatment Crying and movement during the dental sedation Ohio State University Behavioral Rating Scale (OSUBRS) [13]
Children’s pain during the dental sedation Facial expression of pain during the dental procedure under sedation The Faces, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC) [14]
Children’s acceptance of the sedative administration Crying, movement and pain during the sedative administration through the oral and intranasal routes OSUBRS [13] and FLACC [14]
Memory of intraoperative procedures Recall/recognition of pictures and events that occurred throughout dental appointment Three-stage procedure [15] on the treatment day and semistructured interview with parents on the next day
Children’s, parents’, and dentists’ stress Physiological response to stress during dental treatment under conscious sedation Cortisol levels in saliva of all participants and self-report from parents and dentists
Children’s perceptions of sedation How do the children perceive the dental sedation procedure? Semistructured qualitative interview 1 week later
Parents’ and dentists’ perceptions of children’s sedation If parents and dentists are satisfied, feel stress or think that children had pain during the dental sedation Questions answered through a Visual Analog Scale (VAS)
Adverse events Unexpected and undesirable response to sedatives that threaten or cause patient injury or discomfort [16] World SIVA International Sedation Task Force Tool [16]
Economic analysis Cost-effectiveness Decision tree [17]