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Procedural sedation: Aspects on methods, safety and effectiveness
Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Anaesthesiology and Intensive Care in Linköping.
2019 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

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.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2019. , p. 85
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1669
National Category
Anesthesiology and Intensive Care Surgery Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
URN: urn:nbn:se:liu:diva-156720DOI: 10.3384/diss.diva-156720ISBN: 9789176851104 (print)OAI: oai:DiVA.org:liu-156720DiVA, id: diva2:1315254
Public defence
2019-06-05, Berzeliussalen, Campus US, Linköping, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2019-05-13 Created: 2019-05-13 Last updated: 2019-05-16Bibliographically approved
List of papers
1. Sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled study of patient-controlled propofol sedation and that given by a nurse anaesthetist
Open this publication in new window or tab >>Sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled study of patient-controlled propofol sedation and that given by a nurse anaesthetist
Show others...
2015 (English)In: Scandinavian Journal of Gastroenterology, ISSN 0036-5521, E-ISSN 1502-7708, Vol. 50, no 10, p. 1285-1292Article in journal (Refereed) Published
Abstract [en]

Objective: Different regimens are used for sedation during ERCP (endoscopic retrograde cholangiopancreatography). Our objectives were to compare safety, ease of treatment, time to recovery and patients’ experiences using PCS (patient-controlled sedation) with propofol as well as sedation given by a nurse anaesthetist (ACS) with propofol or midazolam during ERCP.

Material and methods: The study included 281 adults in 301 procedures. The PCS group (n=101) delivered bolus doses of 5 mg of propofol according to their need for sedation. The ACS group (n=100) had 2-8 mg/kg/hour of propofol infused, with the target for sedation being Level 3 of the Observer’s Assessment of Alertness/Sedation scale (OAA/S). The control group was given 2-3 mg of midazolam for induction and additional 1 mg if required.

Results: PCS and ACS increased the ease of the procedure and reduced the numbers of sedation failures compared to midazolam sedation (ACS n=0; PCS n=4; midazolam n=20). The ACS group had more deeply sedated patients (OAA/S Level 2), desaturations and obstructed airways than the PCS and midazolam groups. Over 90% of all patients had recovered (Aldrete score≥9) by the time they returned to the ward. PCS resulted in the least fatigue and pain after the procedure. Patients’ preference for PCS and ACS were the same.

Conclusion: PCS with propofol is superior to midazolam and comparable to ACS. PCS resulted in a rapid recovery, tended to be the safest and was almost as effective as ACS in ensuring a successful examination.

Place, publisher, year, edition, pages
Taylor & Francis, 2015
Keywords
Conscious sedation, propofol, Cholangiopancreatography, Endoscopic Retrograde
National Category
Anesthesiology and Intensive Care
Identifiers
urn:nbn:se:liu:diva-112371 (URN)10.3109/00365521.2015.1038848 (DOI)000361324600013 ()
Available from: 2014-11-24 Created: 2014-11-24 Last updated: 2019-05-13Bibliographically approved
2. Rectal ketamine during paediatric burn wound dressing procedures: a randomised dose-finding study
Open this publication in new window or tab >>Rectal ketamine during paediatric burn wound dressing procedures: a randomised dose-finding study
2019 (English)In: Burns, ISSN 0305-4179, E-ISSN 1879-1409, Vol. 45, no 5, p. 1081-1088Article in journal (Refereed) Published
Abstract [en]

Background

Worldwide, ketamine is used during paediatric procedures, but no recommendations are available regarding a suitable dose for rectal administration during procedures involving high levels of pain and/or anxiety such as burn wound dressing change.

Methods

We evaluated three different single doses of rectally administered racemic ketamine mixed with a fixed dose of 0.5 mg/kg of midazolam. In total, 90 children – aged 6 months to 4 years – were randomised 1:1:1 to receive 4 mg/kg (K-4 group), 6 mg/kg (K-6 group) or 8 mg/kg (K-8 group) of racemic ketamine for a maximum of three consecutive procedures. Primary outcome measure was procedural pain evaluated by Face, Legs, Activity, Cry, Consolability (FLACC) behavioural scale. Secondary outcome included feasibility and recovery time. Patient safety was evaluated using surrogate outcomes.

Results

In total, 201 procedures in 90 children aged 19 ± 8 months were completed. The median maximum pain was FLACC 0 in all groups (p = 0.141). The feasibility was better for groups K-6 (p = 0.049) and K-8 (p = 0.027) compared with K-4, and the mean recovery time was the longest for group K-8 (36 ± 22 min) compared with groups K-4 (25 ± 15 min; p = 0.003) and K-6 (27 ± 20 min; p = 0.025). Median maximum sedation measured by the University of Michigan Sedation Scale (UMSS) was higher in group K-8 compared with group K-4 (p < 0.0001) and K-6 (p = 0.023). One child in group K-8 had a study drug-related serious adverse event — laryngospasm/airway obstruction. No rescue analgosedative medication was administered for group K-6.

Conclusions

A rectally administered mixture of racemic ketamine (6 mg/kg) and midazolam (0.5 mg/kg) during paediatric burn dressing procedures with a duration of approximately 30 min provides optimal conditions regarding pain relief, feasibility, recovery time and patient safety, with no need for rescue analgosedative medication.

Place, publisher, year, edition, pages
Pergamon Press, 2019
National Category
Anesthesiology and Intensive Care Public Health, Global Health, Social Medicine and Epidemiology Surgery
Identifiers
urn:nbn:se:liu:diva-156837 (URN)10.1016/j.burns.2018.12.012 (DOI)000470856100010 ()31060760 (PubMedID)2-s2.0-85065014700 (Scopus ID)
Note

Funding agencies: County Council of Ostergotland, Sweden

Available from: 2019-05-14 Created: 2019-05-14 Last updated: 2019-07-15Bibliographically approved

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Department of Clinical and Experimental MedicineFaculty of Medicine and Health SciencesDepartment of Anaesthesiology and Intensive Care in Linköping
Anesthesiology and Intensive CareSurgeryPublic Health, Global Health, Social Medicine and Epidemiology

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