Analgesic Effects of Midazolam in Human Volunteers

Phase 4

Completed

• Conditions: Analgesic Drugs; Antinociceptive Agents
• Interventions: Drug: Isotonic saline; Drug: Midazolam; Drug: Fentanyl

• Registration Number: NCT02629146
• Lead Sponsor: Wilhelminenspital Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-06
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-14
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isotonic saline	Isotonic saline	Drug: Isotonic saline (placebo)
Midazolam	Midazolam	Drug: Midazolam (experimental)
Fentanyl	Fentanyl	Drug: Fentanyl (active comparator)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Schmerzdiagnostik / Clinical Research Unit; 🇦🇹 Vienna, Austria