CompletedPhase 1

Hyperalgesia and Pain

Germany20 participantsStarted 2012-01

Plain-language summary

Evaluation of the effects of 35%/15%/50% N2O/N2/O2 mixtures on the area of hyperalgesia induced by remifentanil in the CCES (Continuous Cutaneous Electrical Stimulation) model in 20 healthy volunteers. The duration of participation for each volunteer is expected to be around 9 weeks with the performance of 4 experimental session 2 weeks apart. The selection visit will last half a day; each experimental session will last half a day; the study end will last 2 hours maximum.

Who can participate

Age range18 Years – 40 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Caucasian healthy male * Able to feel a distinct pin-pick sensation on normal skin * Subject willing and able to complete the requirements of this study * Written informed consent signed prior to any study related procedures Exclusion Criteria: * History of any past or current renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine haematological, neurological, psychiatric disease or other disorders * Any significant history of allergic disease * Acute skin disease, lesions, acute sunburn, extensive tattoos or scars * Donation of blood within the previous 3 months * participation in any other clinical study within the previous 4 weeks.

What they're measuring

Hyperalgesia

Timeframe: at T0, T10, T25, T40, T55, T70, T95, T110, T125, T140 and T155 minutes at each experimental session which will last half day

Trial details

NCT IDNCT01581450

SponsorAir Liquide Santé International

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-04

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