Pregabalin and Remifentanil - Analgesia and Ventilation

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Pregabalin; Drug: Remifentanil; Drug: sugar pill, saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01419405

2011/1380-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 4 patient groups, including a placebo group

Pregabalin/placebo

Experimental group

Treatment:

Drug: Pregabalin

placebo/remifentanil

Active Comparator group

Treatment:

Drug: Remifentanil

placebo/placebo

Placebo Comparator group

Treatment:

Drug: sugar pill, saline infusion

Pregabalin/Remifentanil

Experimental group

Treatment:

Drug: Remifentanil

Drug: Pregabalin