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Intranasal esketamine, fentanyl and placebo are compared in treatment of acute pain in adult patients with minor trauma. Study is blinded randomized placebo-controlled parallel design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine | Experimental | intravenous anaesthetic and analgetic |
|
| Fentanyl Citrate | Active Comparator | intravenous opioid analgetic |
|
| Saline Nasal | Placebo Comparator | intravenous "Natriumklorid b. Braun 9 mg/ml" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine | Drug | anesthetic used as analgetic in subanesthetic doses given intranasally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) change | Numeric rating scale is used to measure pain intensity. Scale is from 0-10. 0 = no pain, 10 = worst imegeable | 15 minutes and 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of patients with NRS change more than -2 | Amount of patients with NRS dropping more than 2 at time poin 15 minutes, 20 minutes and 60 minutes | 15 min, 30 min, 60 min |
| Patient satisfaction (pain management) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Meuronen, MD,PhD | Contact | +35819458711 | anna.meuronen@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Anna Meuronen, MD,PhD | consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyvinkää Hospital | Recruiting | Hyvinkää | Finland |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D005283 | Fentanyl |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
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| Fentanyl Citrate | Drug | intravenous fentanyl given intranasally |
|
|
| Saline Nasal | Drug | intravenous saline given intranasally as placebo |
|
|
Whole experience of pain management on NRS scale from 0-10 (0 = absolutely terrible, 10 = best imagenable)
| 120 min |
| Side effects | 120 min |
| Amount of study drug consumed (doses) | Amount of sturdy drug consumed as doses in the end of study period. One dose is determined by patient weight. | 120 min |
| Need for rescue medication mg (oxycodone) | Amount of oral or intramuscular oxycodone consumption in the end of study period as milligrams | 120 min |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |