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Analgesia in ÖAMTC Helicopter Emergency Service in Austria

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ClinicalTrials.gov Identifier: NCT03760302
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Field Physician Care Analgesics Hypnotics Emergencies Safety Accident Trauma, Multiple Pain, Acute Other: analgesics Other: hypnotics

Study Design
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Study Type : Observational
Actual Enrollment : 35000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Analgesia in ÖAMTC Helicopter Emergency Service in Austria: A Retrospective Analysis
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : October 26, 2019
Actual Study Completion Date : February 26, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patient given analgesics or hypnotics
All patients treated with any kind of analgesics or hypnotics are analyzed and compared.
 Other: analgesics
analgesics given to a patient treated from HEMS

Other: hypnotics
hypnotics given to a patient treated from HEMS


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. Analgesic, drug type [ Time Frame: 2000-2016 ]
    Use of analgesic (n= type of analgesic)

  3. Analgesic, frequency [ Time Frame: 2000-2016 ]
    Use of analgesic (n= frequency how often analgesic is used)

  4. Analgesic, amount of analgesics [ Time Frame: 2000-2016 ]
    Use of analgesic (n= amount of analgesic used in mg or µg)


Secondary Outcome Measures :
  1. Side effects [ Time Frame: 2000-2016 ]
    Type of side effect (respiratory arrest after use, hypoxemia, desaturation (SpO2<90%), dead)

  2. 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)

  3. Severity of side effect [ Time Frame: 2000-2016 ]
    severity of side effect (0=none, 1=mild, 2=moderate, 3=severe, 4=potentially life threatening)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients screened with the described inclusion criteria - eligible to be included in analysis.
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760302


Locations
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Austria
General and Surgical Critical Care Medicine, Medical University of Innsbruck
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Mathias Ströhle, Dr General and Surgical Critical Care Medicine, Medical University of Innsbruck
More Information
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03760302    
Other Study ID Numbers: AN2015-0068 347/4.13 381/5.19
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Multiple Trauma
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
 Wounds and Injuries
Analgesics
Hypnotics and Sedatives
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants