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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03760302
Other study ID # AN2015-0068 347/4.13 381/5.19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date February 26, 2021

Study information

Verified date September 2021
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35000
Est. completion date February 26, 2021
Est. primary completion date October 26, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
analgesics
analgesics given to a patient treated from HEMS
hypnotics
hypnotics given to a patient treated from HEMS

Locations

Country Name City State
Austria General and Surgical Critical Care Medicine, Medical University of Innsbruck Innsbruck

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful analgesia 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
Primary Analgesic, drug type Use of analgesic (n= type of analgesic) 2000-2016
Primary Analgesic, frequency Use of analgesic (n= frequency how often analgesic is used) 2000-2016
Primary Analgesic, amount of analgesics Use of analgesic (n= amount of analgesic used in mg or µg) 2000-2016
Secondary Side effects Type of side effect (respiratory arrest after use, hypoxemia, desaturation (SpO2<90%), dead) 2000-2016
Secondary Frequency of side effects 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
Secondary Severity of side effect severity of side effect (0=none, 1=mild, 2=moderate, 3=severe, 4=potentially life threatening) 2000-2016
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