Skip to main content
OpenTrials
Completed

NCT Number: NCT01419405

Pregabalin and Remifentanil - Analgesia and Ventilation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oslo Universitetssykehus, Rikshospitalet

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

hard capsule, 150 mg, 2 times, 2 days

Other names: Lyrica

Remifentanil

Drug

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

sugar pill, saline infusion

Drug

hard capsule, 150 mg, 2 times, 2 days, saline infusion

Other names: Laktose monohydrat, NaCl 0,9%

Primary outcomes

  1. Pain intensity

    Time frame: 123 sec x 4

    Pain was caused by Cold Pressure Test

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2011
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.