NCT03760302

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

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

First Submitted

Initial submission to the registry

November 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

November 26, 2018

Last Update Submit

September 7, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • Analgesic, drug type

    Use of analgesic (n= type of analgesic)

    2000-2016

  • Analgesic, frequency

    Use of analgesic (n= frequency how often analgesic is used)

    2000-2016

  • Analgesic, amount of analgesics

    Use of analgesic (n= amount of analgesic used in mg or µg)

    2000-2016

Secondary Outcomes (3)

  • Side effects

    2000-2016

  • Frequency of side effects

    2000-2016

  • Severity of side effect

    2000-2016

Study Arms (1)

Patient given analgesics or hypnotics

All patients treated with any kind of analgesics or hypnotics are analyzed and compared.

Other: analgesicsOther: hypnotics

Interventions

analgesics given to a patient treated from HEMS

Patient given analgesics or hypnotics

hypnotics given to a patient treated from HEMS

Patient given analgesics or hypnotics

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients screened with the described inclusion criteria - eligible to be included in analysis.

You may qualify if:

  • Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016

You may not qualify if:

  • No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service. Analgesia given not in the period of examination (2000-2016)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General and Surgical Critical Care Medicine, Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

EmergenciesMultiple TraumaAcute Pain

Interventions

AnalgesicsHypnotics and Sedatives

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesCentral Nervous System Depressants

Study Officials

  • Mathias Ströhle, Dr

    General and Surgical Critical Care Medicine, Medical University of Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 30, 2018

Study Start

December 1, 2018

Primary Completion

October 26, 2019

Study Completion

February 26, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations