Analgesia Clinical Trial
Official title:
The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.
Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.
Status | Recruiting |
Enrollment | 170 |
Est. completion date | September 1, 2025 |
Est. primary completion date | July 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more Exclusion Criteria: - pregnant - <18 years - prisoners - lesions of head, face or abdomen - no consent given or possible - pain not scorable - known drug abuse or substitution therapy - chronic level 3 pain medication - intake of level 3 < 8 hours - intoxicated patient - allergy or intolerance to opiates - renal or hepatic insufficiency - < 50kg body weight - hemodynamic instability |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Saint Pierre | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Saint Pierre |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | number of participants with adverse effects | subjects are questioned and examined for known adverse effects of Sufentanil | at 15-20 and at 60 minutes | |
Primary | change in pain score | pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable) | 15-20 minutes after first administration of Sufentanil | |
Secondary | change in pain score | pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable) | 60 minutes after first administration of Sufentanil |
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