Chest pain or other pain raising suspicion of an acute coronary syndrome. An evaluation of benzodiazipines and prehospital care.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007595-42-SE

Enrollment

2500

Registered

2008-01-17

Start date

2008-04-22

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

This study evaluates the possibility to improve symptoms prior to hospital admission among patients suffering from acute chest pain.

Interventions

Trade Name: Dormicum 1mg/ml Product Name: Dormicum Pharmaceutical Form: Solution for injection INN or Proposed INN: Midazolam CAS Number: 59467-70-8 Concentration unit: mg/ml milligram(s)/millilitre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patient should be seen by the Emergency Medical Service (EMS). 2. Acute chest pain or other symptoms including pain judged as being caused by an acute coronary syndrome. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Age below 18 years 2. Pain caused by trauma 3. Not possible to receive informed consent 4. Unwillingness

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the possibililty for the ambulance staff to relieve and treat pain and anxiety in acute chest pain by one of two types of interventions. The first intervention is a caring intervention where some of the staff have been specifically educated in acute cardiac care and in the process of caring. The second intervention deals with medication, midazolam, a bensodiazepine.;Secondary Objective: The secondary objective of the trial is to evaluate the safety and feasibility of adding midazolam to morphine. ;Primary end point(s): Estimated pain/anxiety on a 10-graded scale where 0 means no symptoms and 10 maximal symptoms	—

Measure

Time frame

Main Objective: To evaluate the possibililty for the ambulance staff to relieve and treat pain and anxiety in acute chest pain by one of two types of interventions. The first intervention is a caring intervention where some of the staff have been specifically educated in acute cardiac care and in the process of caring. The second intervention deals with medication, midazolam, a bensodiazepine.;Secondary Objective: The secondary objective of the trial is to evaluate the safety and feasibility of adding midazolam to morphine. ;Primary end point(s): Estimated pain/anxiety on a 10-graded scale where 0 means no symptoms and 10 maximal symptoms

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026