/A
- Conditions
- Acute pain to be tested in healthy volunteers
- Registration Number
- EUCTR2009-012658-19-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
healthy volunteers, aged 18-45 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Obesity (BMI > 35); Presence of medical disease (heart-, lung-, liver-, kidney-, neurologic disease; diabetes m.; pyrosis; diaphragmatic hernia);
Presence of psychiatric disease; History of chronic alcohol or illicit drug use;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. The study the contribution of the NMDA receptor in the effect of methadon on pain rleief and respiratory depression<br>2. To study the contribution of the mu-opioid receptor in the effect of S(+)-ketamine on pain relief and respiratyory depression.;Secondary Objective: nonen;Primary end point(s): This study is aimed at quantifying the relative contribution of the two major receptor systems involved in S(+)-ketamine and methadone induced analgesia and side effects (respiratory depression, sedation, miosis).
- Secondary Outcome Measures
Name Time Method