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In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.
Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon dioxide tension (mmHg).
Side effects such as nausea and sedation were registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin/placebo | Experimental |
| |
| placebo/remifentanil | Active Comparator |
| |
| placebo/placebo | Placebo Comparator |
| |
| Pregabalin/Remifentanil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | hard capsule, 150 mg, 2 times, 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain was caused by Cold Pressure Test | 123 sec x 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory function | Respiratory frequence (breath/min), tidal volume (mL), minute volume (L)and expiratory end-tidal carbon dioxide tension (mmHg) | 10 min x 4 |
| Cognitive function | Cognitive function was tested using pc-tests like Cambridge Neuropsychological Test Automated Battery (CANTAB) and Stroop-test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Audun Stubhaug, MD, DMedSci, Prof. | Oslo University Hospital HF, Division of Critical Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo Universitetssykehus, Rikshospitalet | Oslo | 0424 | Norway |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Remifentanil | Drug | 50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL |
|
|
| sugar pill, saline infusion | Drug | hard capsule, 150 mg, 2 times, 2 days, saline infusion |
|
|
| 4 min x 4 |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011422 | Propionates |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |