Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:48 AM
Study NCT ID:
NCT07314450
Status:
RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
Sponsor:
Region Zealand
Organization:
Study Overview
Official Title:
Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAINEX
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S-20252000-95 | OTHER | The Committees on Health Research Ethics | View |