Clinical Trial: Hyperalgesia and Pain
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Antihyperalgesic and Analgesic Effects of 35% Nitrous Oxide in a Human Model of Electrically Evoked Hyperalgesia and Pain
Brief 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.
Detailed Summary:
Single site, exploratory, comparative, double-blind, randomised, cross-over study. Three physicians will be involved in the conduct of this study:
- Physician 1 will include and randomise the subjects, prepare and administer the study products (namely Investigational Medicinal Products (IMPs)) in an open manner and will assess subject safety.
- Physician 2, kept IMP blinded, will perform all evaluation measurements and sedation assessments during all experimental sessions. Physician 2 will always be the same person throughout the whole study period.
- Physician 3 will be available if needed to reinforce subject safety
Design: A group of 20 assessable subjects who will undergo 4 randomised experimental sessions of CCES on 4 separate study days, 2 weeks apart preceded by a 2 week period between selection and first experimental session and followed by a 1 week period between last experimental session and study end.
After the selection visit, each visit corresponds to one of the 4 experimental sessions named A, B, C, D differing by the gas mixture inhaled and the intravenous medicine administered.
The order of these experimental sessions A, B, C, D, will be assigned according to a pre-established list that the investigator will not know.
Each experimental session includes a set-up-phase followed by an evaluation phase.
The set up phase will last 20 mn during each an electrical stimulation will generate a spontaneous pain: every 2 minutes the electrical stimulation will increase and the subject will be asked to rate the pain on a
Sponsor: Air Liquide Santé International
Current Primary Outcome: Hyperalgesia [ Time Frame: at T0, T10, T25, T40, T55, T70, T95, T110, T125, T140 and T155 minutes at each experimental session which will last half day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- transcutaneous oxygen saturation [ Time Frame: From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day ]By monitoring pulse oximetry device
- respiration rate [ Time Frame: From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day ]Respiration rate
- systolic and diastolic blood pressures [ Time Frame: From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day ]systolic and diastolic blood pressures
- Heart rate [ Time Frame: From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day ]Measured by cardioscope
- sedation score [ Time Frame: From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day ]sedation score
Original Secondary Outcome: Same as current
Information By: Air Liquide Santé International
Dates:
Date Received: November 30, 2011
Date Started: January 2012
Date Completion:
Last Updated: April 19, 2012
Last Verified: April 2012
