Background: Safety and effectiveness are fundamental principles within the healthcare sector to provide quality of care and health improvement for patients. By ensuring that care is provided based on evidence-based knowledge, risks and complications can be minimised and the use of scarce resources optimised. An increasing demand for diagnostic and therapeutic procedures challenges the traditional methods for sedation regarding safety and effectiveness. It is desirable that the fundamental principles are improved when refining existing or developing new sedation methods. In this doctoral thesis, safety and effectiveness were evaluated for adult patient-controlled sedation (PCS) using propofol during two endoscopic procedures: endoscopic retrograde cholangiopancreaticography (ERCP) and flexible bronchoscopy (FB); and different doses of rectal racemic ketamine for paediatric (< 4 years) burn wound care.

Methods: Data on vital functions, sedation level, safety interventions, procedure feasibility, patient-reported outcome and experience measures, and recovery, from three clinical randomised controlled trials were collected. Costs of sedation for the endoscopic procedures were compiled in a cost-analysis study.

Results: PCS with propofol and bedside anaesthetic personnel was shown to be a safe and effective alternative method of sedation during ERCP and FB compared with intravenous sedation with midazolam. The PCS method gives stable cardiorespiratory conditions with few adverse events and interventions, with a low risk of oversedation. PCS offers similar (FB) or better (ERCP) procedure feasibility and patient satisfaction during the procedures than midazolam. Recovery after PCS is quick, minimises the risk for prolonged hospitalisation and is thereby a potential cost-saving sedation method. The optimal dose of rectal racemic ketamine, 6 mg/kg with the addition of 0.5 mg/kg midazolam during severely painful procedures, gives minimal risk for outbreaks of pain, offers stable vital signs conditions and allows rapid recovery without affecting procedure feasibility.

Conclusions: The sedation method can be adjusted to type of procedure and patient population. PCS with propofol offers an alternative and reliable method for adult sedation during endoscopic procedures, whereas rectal racemic ketamine combined with midazolam provides good conditions for burn care dressing procedures in young children.