Pregabalin and Remifentanil - Analgesia and Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-03-31

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pregabalin/placebo

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

hard capsule, 150 mg, 2 times, 2 days

placebo/remifentanil

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL

placebo/placebo

Group Type PLACEBO_COMPARATOR

sugar pill, saline infusion

Intervention Type DRUG

hard capsule, 150 mg, 2 times, 2 days, saline infusion

Pregabalin/Remifentanil

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

hard capsule, 150 mg, 2 times, 2 days

Remifentanil

Intervention Type DRUG

50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL

Interventions

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Pregabalin

hard capsule, 150 mg, 2 times, 2 days

Intervention Type DRUG

Remifentanil

50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL

Intervention Type DRUG

sugar pill, saline infusion

hard capsule, 150 mg, 2 times, 2 days, saline infusion

Intervention Type DRUG

Other Intervention Names

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Lyrica Ultiva Laktose monohydrat NaCl 0,9%

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes