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Pregabalin and Remifentanil - Analgesia and Ventilation

This study has been completed.
Information provided by (Responsible Party):
Oslo University Hospital Identifier:
First received: June 30, 2011
Last updated: September 11, 2014
Last verified: September 2014
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.

Condition Intervention Phase
Drug: Pregabalin
Drug: Remifentanil
Drug: sugar pill, saline infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: 123 sec x 4 ] [ Designated as safety issue: No ]
    Pain was caused by Cold Pressure Test

Secondary Outcome Measures:
  • Ventilatory function [ Time Frame: 10 min x 4 ] [ Designated as safety issue: No ]
    Respiratory frequence (breath/min), tidal volume (mL), minute volume (L)and expiratory end-tidal carbon dioxide tension (mmHg)

  • Cognitive function [ Time Frame: 4 min x 4 ] [ Designated as safety issue: No ]
    Cognitive function was tested using pc-tests like Cambridge Neuropsychological Test Automated Battery (CANTAB) and Stroop-test

Enrollment: 12
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin/placebo Drug: Pregabalin
hard capsule, 150 mg, 2 times, 2 days
Other Name: Lyrica
Active Comparator: placebo/remifentanil 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
Other Name: Ultiva
Placebo Comparator: placebo/placebo Drug: sugar pill, saline infusion
hard capsule, 150 mg, 2 times, 2 days, saline infusion
Other Names:
  • Laktose monohydrat
  • NaCl 0,9%
Experimental: Pregabalin/Remifentanil Drug: Pregabalin
hard capsule, 150 mg, 2 times, 2 days
Other Name: Lyrica
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
Other Name: Ultiva

Detailed 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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01419405

Oslo Universitetssykehus, Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Audun Stubhaug, MD, DMedSci, Prof. Oslo University Hospital HF, Division of Critical Care
  More Information

Responsible Party: Oslo University Hospital Identifier: NCT01419405     History of Changes
Other Study ID Numbers: 2011/1380-1 
Study First Received: June 30, 2011
Last Updated: September 11, 2014
Health Authority: Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
acute experimental pain
cold pressor test

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs processed this record on October 21, 2016