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

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]