Pregabalin and Remifentanil - Analgesia and Ventilation

NCT01419405 | Completed Phase 4

• 1 other identifier: 2011/1380-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

analgesia; acute experimental pain; cold pressor test; pregabalin; remifentanil

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain was caused by Cold Pressure Test

  123 sec x 4

Secondary Outcomes (2)

• Ventilatory function

  10 min x 4

• Cognitive function

  4 min x 4

Study Arms (4)

Pregabalin/placebo

EXPERIMENTAL

Drug: Pregabalin

placebo/remifentanil

ACTIVE COMPARATOR

Drug: Remifentanil

placebo/placebo

PLACEBO COMPARATOR

Drug: sugar pill, saline infusion

Pregabalin/Remifentanil

EXPERIMENTAL

Drug: Pregabalin; Drug: Remifentanil

Interventions

Pregabalin DRUG

hard capsule, 150 mg, 2 times, 2 days

Also known as: Lyrica

Pregabalin/Remifentanil; Pregabalin/placebo

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

Also known as: Ultiva

Pregabalin/Remifentanil; placebo/remifentanil

sugar pill, saline infusion DRUG

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

Also known as: Laktose monohydrat, NaCl 0,9%

placebo/placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers,
• \> 18 yrs \< 55 yrs,
• negative pregnancy test

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo Universitetssykehus, Rikshospitalet

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Pregabalin; Remifentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Propionates; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Audun Stubhaug, MD, DMedSci, Prof.

  Oslo University Hospital HF, Division of Critical Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: August 18, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

NO (1)