title: The COMFORT behavioural scale provides a useful assessment of sedation, pain and distress in toddlers undergoing minor elective surgery.
abstract: OBJECTIVE
  The COMFORT behavioural scale was developed to assess sedation, pain and distress in children unable to report pain. Our aims were to test construct validity of the scale in toddlers undergoing minor surgery and determine the inter-rater reliability of the scale.
  
  
  METHODS
  We consecutively enrolled 45 children aged 12-36 months from a Norwegian surgical outpatient care unit. The level of sedation, pain and distress was assessed before and after surgery with the COMFORT behavioural scale. Inter-rater reliability was estimated and construct validity was tested based on a priori defined hypotheses. A 2.5-point (15%) change in the scale was considered clinically important.
  
  
  RESULTS
  We obtained 307 scores covering most of the scale's range, but a floor effect was clearly present. Inter-rater reliability was high between assessors (intraclass correlation coefficient = 0.96; 95% CI 0.92-0.98). Clinically important differences were seen between baseline and light sedation (3.1 points, p < 0.001) and between light and deep sedation (4.6 points, p = 0.002). The difference between baseline and our definition of a pain/distress state was not clinically important (1.5 points, p = 0.039).
  
  
  CONCLUSIONS
  The COMFORT behavioural scale can provide one aspect of an overall clinical assessment of sedation, and probably pain and distress, in toddlers before and after surgery.
authors.affiliation: Department of Child and Adolescent Health Services, Telemark Hospital, Skien, Norway.|Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Sweden.
authors.forename: Randi Dovland
authors.identifier: http://orcid.org/0000-0001-6857-7058
authors.initials: RD
authors.lastname: Andersen
authors.affiliation: Department of Research, Telemark Hospital, Skien, Norway.
authors.forename: Tomm
authors.initials: T
authors.lastname: Bernklev
authors.affiliation: Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Sweden.
authors.forename: Ann
authors.initials: A
authors.lastname: Langius-Eklöf
authors.affiliation: Department of Pediatric and Adolescent Medicine, Akershus University Hospital, Lørenskog, Norway.
authors.forename: Britt
authors.initials: B
authors.lastname: Nakstad
authors.affiliation: Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden.|Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge, Huddinge, Sweden.
authors.forename: Leena
authors.initials: L
authors.lastname: Jylli
mesh_terms: D002652:Child Behavior; D002675:Child, Preschool; D016292:Procedural Sedation; D017558:Elective Surgical Procedures / Q000009:adverse effects; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D013511:Minor Surgical Procedures / Q000009:adverse effects; D015588:Observer Variation; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis* / Q000209:etiology; D011446:Prospective Studies; D015203:Reproducibility of Results; D013315:Stress, Psychological / Q000175:diagnosis* / Q000209:etiology
keywords: COMFORT behavioural scale; Pain assessment; Postoperative course; Sedation; Validation studies