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Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm G1800 | Experimental | administration of gabapentin with a gradual increasing dose of up to 1800 mg / day |
|
| G0 | Active Comparator | Standardized medical treatment of central neuropathic pain: metamizole, tramadol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment the analgesic effect of gabapentin | The decrease of the incidence of chronic neuropathic pain in 3 months after initiation of the gabapentin treatment in 3 months after initiation of the gabapentin treatment | in 3 months after initiation of the gabapentin treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The decrease of the incidence of chronic neuropathic pain | The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment | in 6., 9. and 12. months after initiation of the gabapentin treatment |
| The number of painful episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultnà nemocnice Brno | Brno | Czechia |
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| Metamizol | Drug | Standardized treatment |
|
| Tramadol | Drug | Standardized treatment |
|
The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment) |
| in 3., 6., 9. and 12. months after initiation of the gabapentin treatment |
| The decrease of the consumption of rescue medication | The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment | in 3., 6., 9. and 12. months after initiation of the gabapentin treatment |
| Absolute and percentage change in average pain | Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months | in 3., 6., 9. and 12. months |
| Quality of life | Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R | in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D004177 | Dipyrone |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000632 | Aminopyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |
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