nociceptive pain
Conditions
Interventions
Trade Name: Dormicum
Product Name: Dormicum
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: MIDAZOLAM HYDROCHLORIDE
CAS Number: 59467-96-8
Concentration unit: mg/ml milligram
Sponsors
Wilhelminenspital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • male or female • 18-40 years old • healthy • body mass index between 5th and 85th percentile • Caucasian • non smoker or moderate smoker (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • acute or chronic pain condition (except for mild day-to-day pain on <5 days/month) • previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics • symptoms of a clinically relevant illness in the 2 weeks before the first study day • hypertension • any known psychiatric condition • abuse of alcoholic beverages, drug abuse • known positive human immunodeficiency virus status • any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks • participation in a clinical trial in the 4 weeks preceding the study • known allergy against Midazolam • known allergy against Fentanyl • pregnancy or breast-feeding • unable or unwilling to give informed consent • unable or unwilling to follow investigator’s instructions • unable or unwilling to comply with study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the analgesic efficacy of Midazolam.;Secondary Objective: To assess the time course of safety and tolerability of Midazolam in a sedative/analgesic dose (sedation, psychomotor function). To test feasibility of the assessment protocol in sedated young healthy volunteers. To demonstrate validitiy of the assessment protocol via Fentanyl as active control ;Primary end point(s): Analgesic efficacy of the investigational drug as measured by reduction of pain ratings to suprathreshold heat stimuli delivered to the volar forearm with a thermode compared to placebo ;Timepoint(s) of evaluation of this end point: Baseline before drug administration and between 3.5 and 6 minutes after end of the one-minute intravenous drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Analgesic efficacy of the investigational drug as measured by the difference of the means of the electrical pain detection thresholds between the two groups. Analgesic efficacy of the investigational drug as measured by the difference of the means of the pain ratings to electrical suprathreshold pain between the two groups. Safety profile of analgesic dose (respiratory depression, time to cooperation, bispectral index (BIS), adverse events) Assessment of possible late reoccurrence of sedative effects (compared to placebo) using the Richmond Agitation Sedation Scale, the Detection Task, and the Groton Maze Learning Test task. Validity of assessment protocol as measured by reduction of pain ratings to suprathreshold heat pain stimuli after Fentanyl administration compared to placebo. ;Timepoint(s) of evaluation of this end point: Baseline before drug administration and 3.5 to 50 minutes after end of the one-minute intravenous drug administration | — |
Countries
Austria
Contacts
Public ContactVienna Human Pain Research Group
Wilhelminenspital
Outcome results
None listed