Pregabalin and Remifentanil - Analgesia and Ventilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01419405
First received: June 30, 2011
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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
Pain
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov 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:
analgesia
acute experimental pain
cold pressor test
pregabalin
remifentanil

Additional relevant MeSH terms:
Pregabalin
Remifentanil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014