- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03760302
Analgesia in ÖAMTC Helicopter Emergency Service in Austria
September 7, 2021 updated by: Medical University Innsbruck
Analgesia in ÖAMTC Helicopter Emergency Service in Austria: A Retrospective Analysis
A sufficient analgesia in injured or sick people is the main goal of physicians treating a patient.
In emergency medicine potent analgesia like ketamine or opioids are routinely used.
It is unknown if there are any severe side effects or if the use is safe while in use in a Helicopter Emergency Service equipped with emergency physicians.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
35000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Innsbruck, Austria, 6020
- General and Surgical Critical Care Medicine, Medical University of Innsbruck
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients screened with the described inclusion criteria - eligible to be included in analysis.
Description
Inclusion Criteria:
- Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016
Exclusion Criteria:
- No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service. Analgesia given not in the period of examination (2000-2016)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient given analgesics or hypnotics
All patients treated with any kind of analgesics or hypnotics are analyzed and compared.
|
analgesics given to a patient treated from HEMS
hypnotics given to a patient treated from HEMS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful analgesia
Time Frame: 2000-2016
|
Change in reported pain severity before and after treatment with analgesic.
(Numeric Rating Scale, NRS, eleven-point scale reporting no pain=0, to maximum pain=10; 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain)
|
2000-2016
|
Analgesic, drug type
Time Frame: 2000-2016
|
Use of analgesic (n= type of analgesic)
|
2000-2016
|
Analgesic, frequency
Time Frame: 2000-2016
|
Use of analgesic (n= frequency how often analgesic is used)
|
2000-2016
|
Analgesic, amount of analgesics
Time Frame: 2000-2016
|
Use of analgesic (n= amount of analgesic used in mg or µg)
|
2000-2016
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effects
Time Frame: 2000-2016
|
Type of side effect (respiratory arrest after use, hypoxemia, desaturation (SpO2<90%), dead)
|
2000-2016
|
Frequency of side effects
Time Frame: 2000-2016
|
Frequency of side effects (frequency of side effect/n=total number of analgesic use; very common>=1/10, common>=1/100 and<1/10, uncommon >=1/1000 and <1/100, rare >=1/10000 and <1/1000, very rare <1/10000)
|
2000-2016
|
Severity of side effect
Time Frame: 2000-2016
|
severity of side effect (0=none, 1=mild, 2=moderate, 3=severe, 4=potentially life threatening)
|
2000-2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mathias Ströhle, Dr, General and Surgical Critical Care Medicine, Medical University of Innsbruck
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
October 26, 2019
Study Completion (Actual)
February 26, 2021
Study Registration Dates
First Submitted
November 26, 2018
First Submitted That Met QC Criteria
November 29, 2018
First Posted (Actual)
November 30, 2018
Study Record Updates
Last Update Posted (Actual)
September 8, 2021
Last Update Submitted That Met QC Criteria
September 7, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN2015-0068 347/4.13 381/5.19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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