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OpenTrials
Completed

NCT Number: NCT02629146

Analgesic Effects of Midazolam in Human Volunteers

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.

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Key information

Conditions

Analgesic Drugs Antinociceptive Agents

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Schmerzdiagnostik / Clinical Research Unit

Vienna, State of Vienna, 1190, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Other names: Dormicum

Fentanyl

Drug

Isotonic saline

Drug

Primary outcomes

  1. Change in pain ratings (0-100) to a suprathreshold heat pain stimulus

    Time frame: 3.5 Minutes after end of infusion

Secondary outcomes

  1. Change in pain ratings to a suprathreshold electrical pain stimulus

    Time frame: 3.5 Minutes after end of infusion

  2. Increase of pressure pain thresholds (kPa)

    Time frame: Up until 23 Minutes after end of infusion

Sponsors and collaborators

Lead sponsor

Wilhelminenspital Vienna

Other

Collaborators

  • Akron Molecules AG

Registry information

Official study title

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

Acronym: GabA01

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2015
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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