Analgesic Effects of Midazolam in Human Volunteers (GabA01)

Wilhelminenspital Vienna

Status and phase: Completed; Phase 4

Conditions: Analgesic Drugs; Antinociceptive Agents

Treatments: Drug: Fentanyl; Drug: Midazolam; Drug: Isotonic saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02629146

GabA01

Details and patient eligibility

About

This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.

Enrollment: 24 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male and female volunteers
• 18-40 years old
• healthy
• body mass index between 5th and 85th percentile
• Caucasian
• non smoker or moderate smoker (<10 cigarettes per day)
• able to understand, write, and read German

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

Midazolam

Experimental group

Description:

Drug: Midazolam (experimental)

Treatment:

Drug: Midazolam

Isotonic saline

Placebo Comparator group

Description:

Drug: Isotonic saline (placebo)

Treatment:

Drug: Isotonic saline

Fentanyl

Active Comparator group

Description:

Drug: Fentanyl (active comparator)

Treatment:

Drug: Fentanyl