Pregabalin as Adjuvance to Intravenous Opioids

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: April 8, 2014
Last verified: April 2014
  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:


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


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:

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
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, 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: April 8, 2014
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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014