Analgesic Effects of Midazolam in Human Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Single Center, Prospective, Randomized, Double Blind, Placebo-controlled, Three-way Cross-over Study of the Analgesic Effects of Midazolam Versus Placebo With Fentanyl as an Active Control in Human Volunteers

Conditions
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Analgesic Drugs, Antinociceptive Agents

Intervention / Treatment
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* Drug: Midazolam
* Drug: Fentanyl
* Drug: Isotonic saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam<br>Drug: Midazolam (experimental) | Drug: Midazolam<br> <br> * Other names: Dormicum;|
| Placebo Comparator: Isotonic saline<br>Drug: Isotonic saline (placebo) | Drug: Isotonic saline<br> <br> |
| Active Comparator: Fentanyl<br>Drug: Fentanyl (active comparator) | Drug: Fentanyl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain ratings (0-100) to a suprathreshold heat pain stimulus |  | 3.5 Minutes after end of infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain ratings to a suprathreshold electrical pain stimulus |  | 3.5 Minutes after end of infusion | 
| Increase of pressure pain thresholds (kPa) |  | Up until 23 Minutes after end of infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, Fentanyl