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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 function

Cognitive 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

Page last updated: August 23, 2015

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