ClinicalTrials.gov
ClinicalTrials.gov Menu

Pregabalin and Remifentanil - Analgesia and Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01419405
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: Pregabalin Drug: Remifentanil Drug: sugar pill, saline infusion Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil
Study Start Date : December 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 123 sec x 4 ]
    Pain was caused by Cold Pressure Test


Secondary Outcome Measures :
  1. Ventilatory function [ Time Frame: 10 min x 4 ]
    Respiratory frequence (breath/min), tidal volume (mL), minute volume (L)and expiratory end-tidal carbon dioxide tension (mmHg)

  2. Cognitive function [ Time Frame: 4 min x 4 ]
    Cognitive function was tested using pc-tests like Cambridge Neuropsychological Test Automated Battery (CANTAB) and Stroop-test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419405


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

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01419405     History of Changes
Other Study ID Numbers: 2011/1380-1
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Remifentanil
Pregabalin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs