Pregabalin and Remifentanil - Analgesia and Ventilation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil

Conditions
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Pain

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Remifentanil
* Drug: sugar pill, saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers, > 18 yrs < 55 yrs, negative pregnancy test Exclusion Criteria: Pregnancy, nursing, known heart-, lung- or liver disease, kidney failure/peptic ulcers, use of liver enzyme-inducing medications, known allergy against the medications used in the trial, use of psychotropic drugs, analgesics or alcohol used the last 24 hours before the trial, body weight > 100 kg or 30% deviation from normal weight, participant in other studies during the last 2 months, individuals who do not master Norwegian language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin/placebo<br> | Drug: Pregabalin<br>* hard capsule, 150 mg, 2 times, 2 days<br>* Other names: Lyrica;|
| Active Comparator: placebo/remifentanil<br> | Drug: Remifentanil<br>* 50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL<br>* Other names: Ultiva;|
| Placebo Comparator: placebo/placebo<br> | Drug: sugar pill, saline infusion<br>* hard capsule, 150 mg, 2 times, 2 days, saline infusion<br>* Other names: NaCl 0,9%;|
| Experimental: Pregabalin/Remifentanil<br> | Drug: Pregabalin<br>* hard capsule, 150 mg, 2 times, 2 days<br>* Other names: Lyrica;Drug: Remifentanil<br>* 50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL<br>* Other names: Ultiva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain was caused by Cold Pressure Test | 123 sec x 4 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 4 min x 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, acute experimental pain, cold pressor test, pregabalin, remifentanil