Pain, ProceduralPAINEXNCT07314450
Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
An observational study of Pain, Procedural and Analgesia, run by Region Zealand at 3 sites in Denmark.
Trial summary
The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Procedural, Analgesia, Extremity Injury
- How many people
- 200 participants
- Where
- 3 sitesDenmark
- Study dates
- 29 Jul 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients with upper and lower extremity injuries that require painful stabilizing treatment in the emergency department.
Who may be able to join
- Age ≥18.
- Patients with the following injuries are eligible:
- Reduction treatment of shoulder dislocation
- Reduction treatment of elbow dislocation
- Reduction treatment of distal radius fractures, application of cast
- Reduction treatment of finger fractures/dislocation
Show all 19Show fewer
- 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
- Reduction treatment of hip dislocation
- Reduction treatment of patella dislocation
- Reduction of tibial shaft fracture, application of cast
- Reduction treatment of ankle fractures including distal tibia fracture
- Reduction treatment for toe fractures/dislocation
- Casting treatment of lower extremity fractures
- Distal femur fracture, application of cast/traction
- Proximal tibia fracture, application of cast or hinged brace
- Ankle fracture, application of walker
Who cannot join
- Unable to give informed consent (e.g. unconscious, psychotic or dementia)
- Unwilling to participate in the study
- Prior inclusion in the study
- Already included in another clinical study at the same day/hospital visit
- Pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ole Mathiesen, Professor contact
Denmark3 sites, 3 recruiting
- Recruiting
Emergency Department, Holbæk Hospital
Holbæk, Region Sjælland, 4600
Anders Krusenstjerna-Hafstrøm, MD, Andh@regionsjaelland.dk
Martin Schou, MD
- Recruiting
Emergency Department, Zealand University Hospital
Køge, Region Sjælland, 4600
Marie-Laure Bouchy Jacobsson, majaco@regionsjaelland.dk
Marie-Laure Bouchy Jacobsson, MD
- Recruiting
Emergency Department, Odense University Hospital
Odense, Region Syddanmark, 5000
Mikkel Brabrand, Professor, mikkel.brabrand@rsyd.dk
About this study
The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department.
The main questions it aims to answer are:
Read more
- Which sedation and analgesia methods provide the best patient satisfaction and pain relief?
- How do different treatment methods affect clinician satisfaction and the occurrence of adverse events?
The investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation/analgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control.
Participants will:
Be adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures.
Receive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care.
Report their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.
Read the detailed description
Please refer to the full protocol.
- Conditions
- Pain, Procedural, Analgesia, Extremity Injury, Patient Satisfaction, Satisfaction, Personal, Satisfaction
- Being tested
- Usual Care
- Keywords
- Emergency Department, Procedural sedation and analgesia
- Medical subject headings
- Pain, Procedural, Agnosia, Patient Satisfaction, Personal Satisfaction, Arm Injuries, Leg Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareDrug
No intervention: Patients will receive usual care
| Study group | Role | What they receive |
|---|---|---|
| Extremity injuries | 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). Receives: Drug: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction via Numerical Rating Scale
Patient satisfaction with the procedural sedation regimen will be assessed using the 11-point Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores will reflect a better outcome.
Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.
Measured: Immediately after the procedure
Secondary outcomes (4)
Re-call of maximum pain intensity
Re-call of the maximum pain intensity during the treatment procedure will be assessed using the Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores will reflect a worse outcome.
Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.
Measured: Immediately after the procedure
Patient satisfaction via Short Assessment of Patient Satisfaction
Patient satisfaction with the sedation regimen and treatment will be assessed using the Short Assessment of Patient Satisfaction, which consists of 7 items, each scored from 0 to 4, yielding a total score ranging from 0 to 28, with the overall score reflecting a continuum from very dissatisfied to very satisfied. Higher scores will indicate greater patient satisfaction.
Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.
Measured: Immediately after the procedure
Clinician satisfaction with analgosedation regimen
Clinician satisfaction with the analgosedation regimen will be assessed using the Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores will reflect a better outcome.
Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.
Measured: Immediately after the procedure
Incidence of adverse events
Incidence of the following adverse events will be recorded: hypoxia, hypotension, treatment-requiring bradycardia, nausea, vomiting, hallucinations, and the need for reversal agents (antidote medication). Each event will be reported as a dichotomous outcome (present or absent).
Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.
Measured: During and immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start29 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProceduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Odense University Hospital, Holbaek Sygehus
- Responsible party
- Principal investigator, Sophie Sværke, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314450
- Sponsor's protocol ID
- p-2025-19278
- Other IDs
- S-20252000-95
- Acronym
- PAINEX
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
- ClinicalTrials.gov ID
- NCT07314450
- Acronym / sponsor ID
- PAINEX / p-2025-19278
- Conditions
- Pain, Procedural, Analgesia, Extremity Injury, Patient Satisfaction, Satisfaction, Personal, Satisfaction
- Keywords
- Emergency Department, Procedural sedation and analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region ZealandUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Odense University Hospital, Holbaek Sygehus
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department.
The main questions it aims to answer are:
- Which sedation and analgesia methods provide the best patient satisfaction and pain relief?
- How do different treatment methods affect clinician satisfaction and the occurrence of adverse events?
The investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation/analgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control.
Participants will:
Be adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures.
Receive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care.
Report their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.
Detailed description
Please refer to the full protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremity injuries | – | Drug: Usual CareEach 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients with upper and lower extremity injuries that require painful stabilizing treatment in the emergency department.
Key inclusion criteria (19 listed)
- Age ≥18.
- Patients with the following injuries are eligible:
Key exclusion criteria (5 listed)
- Unable to give informed consent (e.g. unconscious, psychotic or dementia)
- Unwilling to participate in the study
- Prior inclusion in the study
- Already included in another clinical study at the same day/hospital visit
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareNo intervention: Patients will receive usual care | Drug | Extremity injuries |
Primary outcome
Patient satisfaction via Numerical Rating Scale
Time frame: Immediately after the procedure
Patient satisfaction with the procedural sedation regimen will be assessed using the 11-point Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores will reflect a better outcome. Patients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.
4 secondary outcomes
Re-call of maximum pain intensity
Time frame: Immediately after the procedure
Patient satisfaction via Short Assessment of Patient Satisfaction
Time frame: Immediately after the procedure
Clinician satisfaction with analgosedation regimen
Time frame: Immediately after the procedure
Incidence of adverse events
Time frame: During and immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
Related trials for Pain, Procedural
Not yet recruiting
Effects of Family-Proxy-Selected Natural Sound Therapy Versus Standardized Natural Sound and Noise Reduction on Procedural Pain During Endotracheal Suctioning in Non-Communicative Mechanically Ventilated Adults: A Four-Arm Randomized Controlled Trial
Procedural Pain During Endotracheal Suctioning
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Not yet recruiting
Leg and Foot Massage for Pain in Newborns Receiving Heel Stick
Procedural Pain in Newborns
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ole Mathiesen, Professor contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Procedural and Analgesia, run by Region Zealand at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Sværke, MD (31368854, Ibes@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction via Numerical Rating Scale (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.