Pregabalin and Remifentanil - Analgesia and Ventilation
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Pregabalin (Drug); Remifentanil (Drug); sugar pill, saline infusion (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Oslo University Hospital Official(s) and/or principal investigator(s): Audun Stubhaug, MD, DMedSci, Prof., Principal Investigator, Affiliation: Oslo University Hospital HF, Division of Critical Care
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.
Clinical Details
Official title: Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Pain intensity
Secondary outcome: Ventilatory functionCognitive function
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Oslo Universitetssykehus, Rikshospitalet, Oslo 0424, Norway
Additional Information
Starting date: December 2011
Last updated: September 11, 2014
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