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Pregabalin as Adjuvance to Intravenous Opioids

This study is currently recruiting participants.
Verified February 2012 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01419405
First received: June 30, 2011
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

The aim of the study is to investigate if pregabalin has a super-additive/synergistic analgetic effect of in combination with the opioid remifentanil.


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: Does Pregabalin, as an Adjuvance to Intravenous Opioids, Has an Additive/ Synergistic Effect on Pain Relief, Respiratory Depression, Sedation and Cognitive Function? A RCT on Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Change in Pain Score on the Visual Analog Scale [ Time Frame: Change in VAS from baseline at 190 minutes ] [ Designated as safety issue: No ]
    Pain is caused by Cold Pressure Test


Secondary Outcome Measures:
  • Change in Respiratory measurements [ Time Frame: Change in Visual Analogue Scale (VAS) from baseline at 190 minutes ] [ Designated as safety issue: No ]
    Respiratory frequence (RF), tidal volume (TV), minute volume (MV)and end-tidal carbon dioxide (etCO2)

  • Change in Cognitive function [ Time Frame: Change in test score from baseline at 190 minutes ] [ Designated as safety issue: No ]
    Cognitve function are tested by standarized pc-tests like Cambridge Neuropsychological Test Automated Battery (CANTAB) and Stroop-test


Estimated Enrollment: 12
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated 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: 0,03 µg/kg/min, 100-140 min: 0,06 µf/kg/min, 150-190 min: 0,12 µg/kg/min
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: 0,03 µg/kg/min, 100-140 min: 0,06 µf/kg/min, 150-190 min: 0,12 µg/kg/min
Other Name: Ultiva

Detailed Description:

In addition to the analgetic effect of the combination pregabalin/remifentanil, we also want to investigate if pregabalins effect on respiratory and cognitive function, is less additive than the analgetic effect. Main outcome will be changes in pain score expressed in Visual Analogue Scale (0-100).

Secondary outcomes are respiratory measurements like respiratory frequency, tidal volume, minute volume and end-tidal CO2.

The influence on cognitive function and sedation level will be measured by computerized tests especially designed for this purpose.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419405

Contacts
Contact: Marianne Myhre, MD 004723072144 marianne.myhre@ous-hf.no
Contact: Audun Stubhaug, Prof dr med 004723073700 audun.stubhaug@medsin.uio.no

Locations
Norway
Oslo Universitetssykehus, Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Marianne Myhre, cand.med.     23072144 ext +47     marianne.myhre@rikshospitalet.no    
Contact: Audun Stubhaug, Prof dr med     23073700 ext +47     audun.stubhaug@medisin.uio.no    
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Audun Stubhaug, Prof dr med 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: February 16, 2012
Health Authority: Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Analgesia
acute pain
cold pressure test
pregabalin
remifentanil

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Remifentanil
Analgesics, Opioid
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants

ClinicalTrials.gov processed this record on June 13, 2013