Hyperalgesia and Pain

This study has been completed.
Sponsor:
Collaborator:
ORION Clinical Services
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01581450
First received: November 30, 2011
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Hyperalgesia
Drug: Nitrous Oxide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Antihyperalgesic and Analgesic Effects of 35% Nitrous Oxide in a Human Model of Electrically Evoked Hyperalgesia and Pain

Resource links provided by NLM:


Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    - Hyperalgesia will be assessed by using a metal rod,(in unit cm).


Secondary Outcome Measures:
  • transcutaneous oxygen saturation [ Time Frame: From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    sedation score


Enrollment: 20
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tested drug
Remifentanil at 0.1 µg/kg/min Tested drug (N2O 35%): 35%/15%/50% N2O/N2/O2
Drug: Nitrous Oxide
35%
Active Comparator: Gas Active control
Remifentanil at 0.1 µg/kg/min Gas active control (N2O 50%):50%/50% N2O/O2
Drug: Nitrous Oxide
50%
Other Name: Kalinox

Detailed Description:

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 visual scale from 0 to 100. When a stable levels of pain intensity will be reached, the regimen of the electrical stimulation will be kept constant up to the end of the experimental session.

The Evaluation phase will last 160 mn : the electrical stimulation will be constant during 160 mn as detailed above. During this phase the subject will inhale a gas mixture with a face mask during 60 minutes combined with an intravenous administration of medicine during 30 mn starting at the same time.

Every 5 minutes the subject will be asked to rate the pain and at predefined times the spontaneous pain and the area of allodynia and hyperalgesia will be measured and recorded as well as safety parameters (transcutaneous oxygen saturation, respiratory parameters, sedation score, blood pressure and heart rate).

The 4 experimental sessions named A, B, C, D differ by the gas mixture inhaled and the intravenous medicine administered.

For the placebo session, inhaled gas mixture will be 50%/50% N2/O2 and intravenous administration will be an isotonic saline solution.

For the three other sessions, inhaled gas mixture will differ from a session to the other one (35%/15%/50% N2O/N2/O2 or 50%/50% N2/O2 or 50%/50% N2O/O2), and remifentanil will be administered intravenously at each of these sessions.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581450

Locations
Germany
University of Erlangen - Nürnberg
Erlangen, Germany, 91054
University of Erlangen - Nürnberg
Erlangen, Germany
Sponsors and Collaborators
Air Liquide Santé International
ORION Clinical Services
Investigators
Principal Investigator: Andreas WEHRFRITZ, MD University of Erlangen-Nürnberg - Germany
  More Information

No publications provided

Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01581450     History of Changes
Other Study ID Numbers: 2011-000966-37
Study First Received: November 30, 2011
Last Updated: April 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Air Liquide Santé International:
Hyperalgesia and pain

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nitrous Oxide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 20, 2014