Hyperalgesia and Pain

Phase 1 Completed 20 enrolled Air Liquide ORION Clinical Services · collab

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start: 2012-01
Primary completion: 2012-04
Completion: 2012-04

Publications

Results Wehrfritz A, Bauer M, Noel N, Ramirez-Gil JF, Ihmsen H, Prottengeier J, Schuttler J, Bessiere B. Evaluation of antihyperalgesic and analgesic effects of 35% nitrous oxide when combined with remifentanil: A randomised phase 1 trial in volunteers. Eur J Anaesthesiol. 2021 Dec 1;38(12):1230-1241. doi: 10.1097/EJA.0000000000001468.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Nitrous Oxide	Other / unclassified	35 %	Inhaled
Comparator	Nitrous Oxide	Other / unclassified	50 %	Inhaled

Indications

No indication recorded.