Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
Conditions: Pain, Procedural, Analgesia, Extremity Injury, Patient Satisfaction, Satisfaction, Personal, Satisfaction, Upper Extremity Injury, Lower Extremity Fracture, Upper Extremity Fracture, Extremity Injuries Lower
Sponsor: Region Zealand

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Procedural sedation and analgesia for treatment 
of adults with fractures and dislocations in the 
emergency department. 
(Protocol for the PAINEX study) 
 
 
 
 
 
 
 
 
 
Primary Investigator 
Sophie Sværke, M.D. 
Registrar and PhD-fellow in Emergency Medicine 
Department of Emergency Medicine 
Holbæk Hospital, Smedelundsgade 60, 4300 Holbæk 
Odense University Hospital, J.B. Winsløws Vej 4, 5000 Odense 
 
 
 
 
 

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Administrative details 
 
Primary investigator 
Sophie Sværke, M.D, PhD-student  
Department of Emergency Medicine, Holbæk Hospital 
Department of Emergency Medicine, Odense University Hospital 
 
Research team 
Co-investigators: 
Mikkel Brabrand, Clinical Professor, PhD, M.D, Consultant 
Department of Emergency Medicine, Odense University Hospital 
Department of Clinical Medicine, University of Southern Denmark 
 
Ole Mathiesen, Clinical Professor, PhD, M.D, Consultant 
Department of Anesthesiology, Zealand University Hospital, Køge 
Department of Clinical Medicine, University of Copenhagen 
 
Anders Krusenstjerna-Hafstrøm, Associate Professor, M.D, Consultant 
Department of Emergency Medicine, Holbæk Hospital 
 
Bjarke Viberg, Professor, PhD, M.D, Consultant 
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital 
Department of Clinical Medicine, University of Southern Denmark 
 
Local site investigator Zealand University Hospital Køge:  
Marie-Laure Bouchy Jacobsson, Clinical Assistant Professor, M.D, Consultant 
Emergency Department, Zealand University Hospital – Køge, Denmark 
Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen 
University, Denmark 
 
Local site investigator Holbæk Hospital: 
Martin Schou M.D, PhD, Consultant 
Department of Emergency Medicine, Holbæk Hospital 
 

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Summary 
 
Background 
Each year, around 80,000 patients in Denmark suffer from painful fractures where 60% 
involves the hip, ancle, foot, upper arm, forearm, or fingers [1]. A substantial part of these 
injuries requires reduction treatment – a necessary painful stabilizing treatment in the 
emergency department. Physicians are trying to ease this pain with different types of 
medications for procedural sedation and analgesia. Systemic procedural sedation and/or 
analgesia or treatment with nerve or hematoma blocks depends on the injury but faces 
different challenges tied to choice of medication and administration route. These challenges 
include patient satisfaction and sufficient analgesic effect since several patients still 
experience considerably pain regardless of strong opioids. With focus on patient satisfaction 
and pain reduction, the best method for procedural sedation and analgesia for these types of 
injuries, remain unclear – but are very important aspects for both patients and physicians. 
 
Aim 
To describe patient satisfaction, pain-relieving effect, clinicians’ satisfaction and adverse 
events of different procedural sedative and analgesic treatment options for adults with upper 
and lower extremity injuries in the emergency department at Odense University Hospital, 
Holbæk Hospital, and Zealand University Hospital, Køge.  
 
Methods 
This prospective observational cohort study will be reported following “The Strengthening the 
Reporting of Observational Studies in Epidemiology Statement: Guidelines for reporting 
observational studies” (STROBE guidelines) to evaluate the effectiveness of different 
procedural sedative and analgesic treatment options in three emergency departments.  
 
The study will assess: Patient- and clinicians’ satisfaction with procedural sedation and 
analgesia, pain levels before, under and after treatment, incidence of selected adverse 
events and usage of antidotes.  
 
Eligible patients are: Adult patients with upper or lower extremity injuries that require painful 
stabilizing treatment. Data will be collected over a selected period of six months. 
 
 
 
 

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Detailed description 
 
Background 
Each year around 80,000 patients in Denmark suffer from painful fractures where 60% 
involves the hip, ancle, foot, upper arm, forearm, or fingers [1]. A substantial part of these 
injuries require stabilizing reduction treatment – a necessary but painful procedure 
performed in the emergency department [2]. To alleviate pain and discomfort, physicians use 
various types and combinations of medications for procedural sedation and analgesia [3, 4]. 
 
Procedural sedation and analgesia are described in the literature as the use of sedative, 
analgesic or dissociative drugs to relieve anxiety and pain associated with diagnostic or 
therapeutic procedures [5]. It is practiced daily in the emergency department for various 
types of procedures [6]. Recently, data on local practices and available medication used for 
procedural sedation and analgesia was collected from 21 different Danish emergency 
departments. Most departments used analgesics like morphine, fentanyl, and paracetamol 
as monotherapy or combined with sedatives such as midazolam or diazepam. Other 
medications available for procedural sedation and analgesia included alfentanil, intravenous 
ketamine, intranasal sufentanil combined with ketamine, N2O, remimazolam, or intravenous 
ketorolac. While some departments facilitated a broad range of analgosedatives, while 
others favored a more limited selection. The study did not specify the choice of medications 
for particular procedures or types of injuries. 
 
Nationally and internationally, hematoma blocks are also a commonly used treatment 
method for managing pain in distal radius fractures and in certain countries no analgesia is 
administrated during treatment of distal radius fractures despite pain [7-9]. Other nerve 
blocks such as interscalene- or infraclavicular blocks may be used for reduction treatment of 
shoulder or elbow dislocations e.g.  [10] [11].   
 
Usage of procedural sedation and analgesia in the emergency department faces different 
challenges depending on the choice of medication and administration route. Patient 
satisfaction is a very important factor which can rely on these factors. A 2023 meta-analysis of 
52 randomized controlled trials with adult patients undergoing procedural analgosedation for 
different procedures, found ketamine-propofol to increase patient satisfaction compared to 
midazolam-opioid [12], which is widely used. Other challenges include the fact that patients 
still may experience significant pain despite the use of strong opioids. A Danish review 
evaluating 2,348 patients treated with intravenous fentanyl by paramedics, found that while 
fentanyl reduced pain levels >2 points on the numerical rating scale for 79.3% of patients, 
60% of patients still reported moderate to severe pain at hospital arrival [13, 14]. Patients 

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undergoing closed reduction treatment for distal forearm fractures are often treated with 
hematoma blocks alone, but research points in different directions and some available 
studies suggest only mild pain relief [15] while others find hematoma blocks comparable to 
intravenous procedural sedation and analgesia [8]. 
 
Another potential challenge with procedural sedation and analgesia is safety. A 2024 meta-
analysis [16] reviewed 32 randomized controlled trials involving a total of 6,377 procedural 
sedations, identifying hypoxia as the most common adverse effect, occurring at a rate of 78.5 
per 1,000 sedations [16]. Other frequent adverse events included apnea (31 per 1,000 
sedations) and hypotension (28.1 per 1,000 sedations). Severe adverse events were rare: 
bradycardia occurred in 16.7 per 1,000, laryngospasm in 2.9 per 1,000, intubation in 10.8 per 
1,000, and aspiration in 2.7 per 1,000 [16]. One of the most frequently employed regimens, 
the combination of midazolam and opioids, was specifically associated with hypotension 
(1.7%), bradycardia (3.2%), apnea (1.7%), hypoxia (5.3%), agitation (1.3%), and vomiting 
(1.3%) [16]. The same review identified ketamine as the safest option for minimizing 
respiratory adverse events, showing the lowest rates of apnea and hypoxia compared to other 
sedatives, including midazolam, diazepam, ketofol, etomidate, propofol, alfentanil, and 
combinations such as ketamine with propofol or midazolam with opioids [16].  
 
The optimal method for procedural sedation and/or analgesia of some of the most frequent 
upper and lower extremity injuries treated in the emergency department - remains unclear 
when it comes to patient satisfaction, pain relief and safety, which are essential factors for 
both patients and physicians. This prospective cohort study therefore aims to evaluate 
patient satisfaction, pain-relieving effect, clinicians’ satisfaction, and adverse events 
associated with different standard procedural sedative and/or analgesic methods used for 
adults with upper and lower extremity injuries in the emergency departments of Odense 
University Hospital, Holbæk Hospital and Zealand University Hospital, Køge.  
 
Objective and aim 
To investigate patient satisfaction, pain-relieving effect, clinicians’ satisfaction and adverse 
events of different standard treatment options used in clinical practice for routine procedural 
sedation and/or analgesia in adults at the emergency departments of Odense University 
Hospital, Holbæk Hospital and Zealand University Hospital, Køge.  
 
Methods 
Study design 
This study is a prospective observational cohort study. It will be reported following “The 
Strengthening the Reporting of Observational Studies in Epidemiology Statement: Guidelines 
for reporting observational studies (STROBE guidelines)” [17]. 

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Patients 
Eligible patients with upper and lower extremity injuries that require painful stabilizing 
treatment in the emergency department. 
 
Inclusion criteria 
1. Age ≥18. 
2. Patients with the following injuries are eligible: 
a) Reduction treatment of shoulder dislocation 
b) Reduction treatment of elbow dislocation 
c) Reduction treatment of distal radius fractures, application of cast 
d) Reduction treatment of finger fractures/dislocation 
e) Casting treatment of upper extremity fractures 
• Proximal humerus fracture, application of fixed sling 
• Humeral shaft fracture, application of Sarmiento brace 
• Supracondylar fracture, application of angled cast 
f) Reduction treatment of hip dislocation 
g) Reduction treatment of patella dislocation 
h) Reduction of tibial shaft fracture, application of cast 
i) Reduction treatment of ancle fractures including distal tibia fracture 
j) Reduction treatment for toe fractures/dislocation 
k) Casting treatment of lower extremity fractures 
• Distal femur fracture, application of cast/traction 
• Proximal tibia fracture, application of cast or hinged brace 
• Ancle fracture, application of walker 
 
Exclusion criteria 
1. Unable to give informed consent (e.g. unconscious, psychotic or dementia)   
2. Unwilling to participate in the study 
3. Prior inclusion in the study 
4. Already included in another clinical study at the same day/hospital visit 
5. Pregnant or breastfeeding  
 
Procedural sedation 
Each department will collect data on the treatment patients with the upper and lower 
extremity injuries receive during reduction or stabilizing treatment (procedural sedation 
and/or analgesia, or no treatment).   
 

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Outcomes 
Primary outcome  
Patient satisfaction with procedural sedation regime measured using numerical rating scale 
[18] when awake and alert before discharge from the emergency department. 
 
Secondary outcomes 
1. Re-call of maximal pain score during treatment procedure using the Numerical Rating 
Scale [18], asked when awake and alert before discharge from the emergency 
department. 
2. Patient satisfaction with the sedation regime and treatment measured with the Short 
Assessment of Patient Satisfaction (SAPS) [19]. 
3. Clinician’s satisfaction with the analgosedation using the Numerical Rating Scale 
[18], after completed procedure. 
4. Incidence of following adverse events: Hypoxia, hypotension, treatment requiring 
bradycardia, nausea, vomiting, or hallucinations, and need of reversal agents 
(antidote medication) 
 
Explorative outcomes 
1. Patient satisfaction with sedation regime and treatment via a 5-point Likert Scale [20], 
asked when awake and alert before discharge from the emergency department. 
2. The incidence of procedural amnesia (patient reported outcome). 
3. Dissociative experience during treatment (patient and physician reported outcome).  
 
Description of outcome measures 
Numerical rating scale (NRS) 
We will use the numerical rating scale to evaluate the primary outcome (patient satisfaction 
with procedural sedation regime) and secondary outcome – clinician satisfaction. The 
numerical rating scale is an 11-point scale ranging from 0 to 10 and can be used to measure 
patient satisfaction and clinician satisfaction where 0 = totally dissatisfied and 10 = totally 
satisfied. Patient and clinicians will be asked for the number corresponding to their level of 
satisfaction with the procedural sedation. Patients will be asked when awake and alert before 
discharge from the emergency department and clinicians after completed procedure.  
 
We will also use the numerical rating scale to measure the intensity of pain. It is simple and 
allows patients to self-report their pain level using a numeric value, providing a 
straightforward and standardized way to evaluate and monitor pain in clinical settings [18, 21, 
22]. The numerical rating scale used to measure pain level ranges from 0 to 10 where: 0 
represents “no pain” and 10 represents “the worst imaginable pain” [18, 21, 22]. Before 
discharge, and when the patient is awake and relevant, we will ask patients about their level 

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of experienced pain on the numerical rating scale (0-10 scale): 1) Before administration of 
procedural sedation (recall), 2) pain level during the procedure (recall) and 3) after procedure 
at discharge (post-procedure). These scores will be used to evaluate the effectiveness of 
different analgesics in reducing patients' pain intensity. 
 
Short assessment of patient satisfaction (SAPS) 
The short assessment of patient satisfaction is a brief, validated questionnaire designed to 
measure patients’ satisfaction in a quick and efficient manner. It evaluates key aspects of 
healthcare experiences, making it suitable for assessing overall patient satisfaction [19]. It 
will consist of 7–10 short items and uses the rating system from the 5-point Likert scale that 
patients are already introduced into with “Very Dissatisfied” to “Very Satisfied”.  
 
5-point Likert scale 
The 5-point Likert scale is a commonly used survey tool to measure levels of satisfaction with 
different treatments or outcomes  [20, 23]. We will use it besides the numerical rating scale to 
measure patient satisfaction with the procedural sedation treatment. It provides the patients 
with five response options that reflect varying degrees of satisfaction. The scale includes both 
positive and negative endpoints, allowing patients to express their experiences in a 
structured manner [23]. 
 
The 5-point Likert Scale is divided into the following answers:  
1. Very dissatisfied 
2. Dissatisfied 
3. Neutral (or neither satisfied nor dissatisfied) 
4. Satisfied 
5. Very satisfied 
 
We will use the 5-point Likert scale in collaboration with the numerical rating scale to 
determine the minimal important difference of patient satisfaction with procedural sedation. 
Patients will be asked when awake and alert before discharge from the emergency 
department. 
 
Sample size 
The sample size will be a non-consecutive convenience sample with inclusion of eligible 
patients over a six-month period beginning from July 2025. 
 
 

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Statistical analysis 
The study is an observational cohort study. We will use R version 4.1.0. to analyze data when 
necessary. The analysis will include patient satisfaction, type of injury, type of analgetic, and 
a description of patients’ baseline characteristics. They will be summarized using appropriate 
descriptive statistics. If any data is missing, we will describe this.  
 
Continuous variables will be presented as either mean and standard deviation (SD) for 
normally distributed data or median and interquartile range (IQR) for non-normally distributed 
data. Categorical variables will be reported as frequencies and percentages.  
 
We will use the results from the 5-point Likert Scale as an anchor to evaluate Minimal 
Important Difference (MID) for patient satisfaction, defined as the difference in pain (on the 
NRS scale) between patients who reported no pain, versus patients who reported mild pain 
as well as in patients with mild pain, moderate pain or severe pain. This will help us evaluate 
the clinical relevance of the findings.  
 
Ethical considerations and protection of data 
The study will assess the procedural sedative and/or analgesic methods currently used in 
emergency departments, which poses no additional risk to patients. No changes to current 
treatments will be employed because of the study, as patients are treated as usual. The study 
will be registered at Clinicaltrials.gov and patients will be asked for informed oral and written 
consent accordant to Danish law.  
 
This protocol has obtained permission according to Danish legalization. It is registered and 
approved in PRVACY in the Region Zealand and Research Registry for Health Science in the 
Region of Southern Denmark. The head of department of each participating department has 
approved the study can be conducted in their departments. This research group has agreed 
on a shared data responsibility and a legal contract was made by SDU Rio to cover all aspects 
of data protection and sharing between the two regions. The research group has also signed a 
contract of collaborative research. All data is collected electronically and stored safely. The 
data is stored regarding to General Data Protection Regulation (GDPR) in an electronic 
password protected database in REDCap. The REDCap database is anchored in the Region of 
Zealand. 
 
Data management 
Data collection 
A local site investigator and the research team will be responsible for inclusion at each site, 
and a selection of local staff will take part in inclusion of patients and collection of data after 
training by the primary investigator. The data will be collected and typed directly into REDCap.  

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The following data will be collected at inclusion: 
1) Date of arrival. 
2) Primary diagnosis. 
3) Treatment/procedure. 
 
 
The following data will be collected post procedure, when patient is awake and alert (before 
discharge from the emergency department):   
1) Patient characteristics:  
a) Age 
b) Sex 
c) Weight 
d) American Society of Anesthesiologists classification (ASA class) 
2) Type of any analgesics before arrival (including no medication taken) 
3) Number of strategies used for procedural sedation and/or analgesic (including no 
medication used) (if shifting medication or administration route during procedure to 
accomplish e.g. reduction treatment) 
Following data will be collected for each strategy:  
a) Medication and dosage 
b) Administration route (oral, intravenous, intranasal, local (block) or intramuscular) 
c) Requirement for supplemental analgesics 
d) Usage of antidotes: Naloxone or flumazenil  
e) Number of reduction attempts, success with reduction (yes/know) 
f) Need of general anesthesia to accomplish desired procedure 
4) Patient satisfaction with sedation measured using the “Numerical Rating Scale” (0-10) [18] 
measured before discharge. 
5) Patient satisfaction via the “Short Assessment of Patient Satisfaction” [19] measured 
before discharge. 
6) Clinician satisfaction with the analgosedation using the numerical rating scale [18], after 
completed procedure. 
7) Selected adverse events and serious adverse events (reported by clinician in patient 
journal in relation to procedural sedation): Hypoxia (drop of saturation SpO2 of >5% from 
baseline measured on peripheral saturation monitoring), hypotension (Mean Arterial Pressure 
<65), treatment requiring bradycardia, vomiting or hallucinations (objective assessment by 
treating physician). 
8) Experience of pain level on the numerical rating scale (0-10 scale): a) Before administration 
of procedural sedation (recall), b) max pain level during the procedure (recall) and c) after 
procedure before discharge (post-procedure pain level). [18] 
9) Incidence of procedural amnesia (yes/no), measured before discharge 
10) Dissociative experience during treatment (good dreams or bad dreams) 

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11) Patient satisfaction via a “5-point Likert Scale” [20] measured before discharge. 
12) Patient contact information if interested in study results or to become part of the patient 
steering committee for future studies. 
 
Handling 
All information will be treated confidentially according to GDPR, and patients will be 
anonymized in the reporting of the study.  
 
Study organization 
This organization is a collaboration between emergency medicine, orthopedics and 
anesthesiology researchers. All researchers have experience with procedural sedation for 
emergency department injuries, and at all participating sites, emergency medicine physicians 
are in charge of both emergency department injury treatment and procedural sedation.  
 
Conflicts of Interest 
The investigators have no conflict of interest. 
 
Financing 
The study is fully funded and has received funding from: 
Brødrene Hartmanns Fond. 
Danmarks Frie Forskningsfond. 
Emergency Department, Holbæk Hospital. 
Else og Mogens Wedell-Weddelsborgs Fund. 
Kong Christian den tiendes Fond. 
L.F Foghts Fond. 
Ingeniør K.A Rhode og Hustrus Legat. 
Odense University Hospital PhD Fund. 
Region of Zealand. 
Region of Southern Denmark. 
Region of Southern Denmark and Region of Zealand Common Fund.  
 
Timeline 
This study is expected to begin in July 2025 and last six months after required approvals and 
registrations.  
 
Perspectives 
This study aims to evaluate patient satisfaction, analgesic efficacy, clinician satisfaction and 
adverse events with existing procedural sedative and/or analgesics treatments in the 
emergency department for patients with upper and lower extremity injuries. Annually 80,000 

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patients in Denmark suffer from painful fractures where 60% involves the hip, ancle, foot, 
upper arm, forearm, or fingers, yet few studies have focused on patient satisfaction in acute 
care settings [1]. Currently, no research has examined patient satisfaction with different 
approaches to procedural sedation and/or analgesia in the emergency department. By 
assessing these factors, the study will contribute to highlight key issues concerning the 
quality and safety of treatment practices, ensuring that patients receive the most effective 
and patient-centered care. 
Disseminations of results 
Expected results, implementation and publication 
The results are expected to generate at least one publication in a national or international 
peer-reviewed journal, preferably as open access publications. Results will be presented at 
relevant national conferences or meetings. All results (positive, negative or inconclusive) will 
be published. Included patients will be informed if they wish to. 
 
Authorship 
Authorship will be granted according to the Vancouver rules for authorship and will occur in 
the following order:  
1. Sophie Sværke  
2. Martin Schou 
3. Marie-Laure Bouchy Jacobsson 
4. Camilla Hedegaard Riis 
5. Anders Krusenstjerna-Hafstrøm 
6. Bjarke Løvbjerg Viberg 
7. Mikkel Brabrand 
8. Ole Mathiesen 
 
N.B. Changes might appear, and further authors might be added but Sophie Sværke will 
remain 1st author and Ole Mathiesen last author.  
 
 
 
 
 
 
 
 
 
 
 
 
 

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