Pregabalin and Remifentanil - Analgesia and Ventilation

September 11, 2014 updated by: Oslo University Hospital

Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo Universitetssykehus, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin/placebo
Drug: Pregabalin
hard capsule, 150 mg, 2 times, 2 days
Other Names:
  • 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 Names:
  • Ultiva
Placebo Comparator: placebo/placebo
Drug: sugar pill, saline infusion
hard capsule, 150 mg, 2 times, 2 days, saline infusion
Other Names:
  • NaCl 0,9%
  • Laktose monohydrat
Experimental: Pregabalin/Remifentanil
Drug: Pregabalin
hard capsule, 150 mg, 2 times, 2 days
Other Names:
  • 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 Names:
  • Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 123 sec x 4
Pain was caused by Cold Pressure Test
123 sec x 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 min x 4
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
4 min x 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Audun Stubhaug, MD, DMedSci, Prof., Oslo University Hospital HF, Division of Critical Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 30, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1380-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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