NCT02629146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

December 6, 2015

Last Update Submit

March 10, 2016

Conditions

Analgesic DrugsAntinociceptive Agents

Keywords

MidazolamFentanyl

Outcome Measures

Primary Outcomes (1)

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

    3.5 Minutes after end of infusion

Secondary Outcomes (2)

  • 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

Study Arms (3)

Midazolam

EXPERIMENTAL

Drug: Midazolam (experimental)

Drug: Midazolam

Isotonic saline

PLACEBO COMPARATOR

Drug: Isotonic saline (placebo)

Drug: Isotonic saline

Fentanyl

ACTIVE COMPARATOR

Drug: Fentanyl (active comparator)

Drug: Fentanyl

Interventions

MidazolamDRUG
Also known as: Dormicum
Midazolam
FentanylDRUG
Fentanyl
Isotonic salineDRUG
Isotonic saline

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male and female volunteers
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schmerzdiagnostik / Clinical Research Unit

Vienna, Vienna, 1190, Austria

Location

Related Publications (1)

  • Laursen DR, Nejstgaard CH, Bjorkedal E, Frost AD, Hansen MR, Paludan-Muller AS, Prosenz J, Werner CP, Hrobjartsson A. Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo. Cochrane Database Syst Rev. 2023 Mar 6;3(3):MR000055. doi: 10.1002/14651858.MR000055.pub2.

    PMID: 36877132DERIVED

MeSH Terms

Interventions

MidazolamFentanylSodium Chloride

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Burkhard Gustorff, Prof.Dr.

    Wilhelminenspital Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.Prof. Dr.

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 14, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 11, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)