Analgesic Effects of Midazolam in Human Volunteers

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02629146

Acronym

GabA01

Enrollment

Registered

2015-12-14

Start date

2015-12-31

Completion date

2016-03-31

Last updated

2016-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesic Drugs, Antinociceptive Agents

Keywords

Midazolam, Fentanyl

Brief summary

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.

Interventions

DRUGMidazolam

DRUGFentanyl

DRUGIsotonic saline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026