Analgesia, Emergencies, Pain, Acute, Sufentanil
Conditions
Keywords
emergency, pain, analgesia, intranasal, sufentanil
Brief summary
Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.
Detailed description
In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm. The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil. Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.
Interventions
DRUGSufentanil
intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in pain score | 15-20 minutes after first administration of Sufentanil | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in pain score | 60 minutes after first administration of Sufentanil | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of participants with adverse effects | at 15-20 and at 60 minutes | subjects are questioned and examined for known adverse effects of Sufentanil |
Countries
Belgium
Contacts
Primary ContactBernard Kreps, MD
Backup ContactStefano Malinverni, MD
Outcome results
None listed