A multinational, observational study to investigate the use of dexmedetomidine (dexdor®) in clinical practice (DEXDUS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective observational study

Population studied

• Short description of the study population:
  All patients who were treated with Dexdor in participating sites.
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To investigate the use of dexdor in clinical practice
• Data analysis plan:
  To evaluate the observed compliance with the current marketing license.