Analgesic Effects of Midazolam in Human Volunteers

Analgesic Drugs Clinical Trial

— GabA01  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629146
• Other study ID #: GabA01
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2015
• Last updated: March 10, 2016
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Wilhelminenspital Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Analgesic Drugs
• Antinociceptive Agents

Intervention

Drug:
• Midazolam

• Fentanyl

• Isotonic saline

Locations

Country	Name	City	State
Austria	Schmerzdiagnostik / Clinical Research Unit	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Wilhelminenspital Vienna	Akron Molecules AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain ratings (0-100) to a suprathreshold heat pain stimulus		3.5 Minutes after end of infusion	No
Secondary	Change in pain ratings to a suprathreshold electrical pain stimulus		3.5 Minutes after end of infusion	No
Secondary	Increase of pressure pain thresholds (kPa)		Up until 23 Minutes after end of infusion	No