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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
| SFMU | UNKNOWN |
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Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED).
The investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED.
The investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates.
The investigators also asses side effects and patient satisfaction in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IN Sufentanil AND IV Placebo | Experimental | Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration |
|
| IV Morphine AND IN Placebo | Active Comparator | Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | Intravenous administration Patient receives simultaneously IV morphine administration and IN placebo spray. Pain is controlled by:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of Analgesia | Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid-related side effects | Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration. Proportion of patients having opioid-related side effects. | 10 minutes |
| Efficiency of Analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department - Hospital Albertville | Albertville | France | ||||
| Emergency Department - Hospital Annecy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31310600 | Result | Blancher M, Maignan M, Clape C, Quesada JL, Collomb-Muret R, Albasini F, Ageron FX, Fey S, Wuyts A, Banihachemi JJ, Bertrand B, Lehmann A, Bollart C, Debaty G, Briot R, Viglino D. Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study. PLoS Med. 2019 Jul 16;16(7):e1002849. doi: 10.1371/journal.pmed.1002849. eCollection 2019 Jul. |
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|
| Sufentanil | Drug | Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV placebo administration and IN sufentanil spray. Pain is controlled by:
|
|
| Placebo | Drug | Intravenous administration Patient receives simultaneously IV placebo administration and IN sufentanil spray. Pain is controlled by:
|
|
|
| Placebo | Drug | Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV morphine administration and IN placebo spray. Pain is controlled by:
|
|
|
Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 10 minutes and 20 minutes after the first opiate administration.
| Every 10 minutes |
| Patient Satisfaction | 40 min |
| Specific Analysis for the pre hospital setting group: Efficiency of Analgesia | Patient self-assessed pain intensity, using Numeric Pain Rating Scale (0 to 10) at 10, 20 and 30 min after the first opiate administration | Every 10 minutes |
| Annecy |
| France |
| Emergency Department - Hospital Chambéry | Chambéry | France |
| Emergency Department - University Hospital of Grenoble | Grenoble | France |
| Emergency Department - Hospital Saint Jean de Maurienne | Saint-Jean-de-Maurienne | France |
| Emergency Department - Hospital Voiron | Voiron | France |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D017409 | Sufentanil |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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