Post Traumatic PainNCT03730272
Occurence of Pain and Use of Analgesic Treatment in Multi-trauma Patients of Intermediate Seveity
An observational study of Post Traumatic Pain and Post Traumatic Analgesic Treatment, run by Oslo University Hospital at 1 site in Norway.
Trial summary
To register the perceived pain score during 0-14 days after multitrauma in conscious patients and to register the use (type and dose) of analgesic treatment in the same period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Pain, Post Traumatic Analgesic Treatment
- What is being tested?
- analgesic drugs and methods
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2018to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients With any kind of multitrauma, fullfilling inclusion/exclusion
Who may be able to join
- Patient With trauma, ISS > 8
Who cannot join
- Unconscious patients at admission
- patients due for major surgery within 3 hrs of admission
- patients primary admitted to other hospitals
- not able to communicate in Norewegian
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, 0407
Johan Raeder, PhD, 004792249669, johan.rader@medisin.uio.no
About this study
Official title: The Incidence and Strenght of Pain in Conscious Multitrauma Patients, 0-14 Days After Multitrauma
To register the perceived pain score during 0-14 days after multitrauma in conscious patients and to register the use (type and dose) of analgesic treatment in the same period.
- Being tested
- analgesic drugs and methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analgesic drugs and methodsDrug
the patient will receive analgesic treatment at the discretion of the physician in charge
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst pain
NRS scale, 0-10
Measured: 0-14 days
Average pain
NRS scale, 0-10
Measured: 0-14 days
Secondary outcomes (1)
analgesic methods
list of drugs (dose and duration) and other analgesic measures
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Aug 2018
- Primary completionMar 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan C Ræder, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730272
- Sponsor's protocol ID
- Trauma.pain.Gyda
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Strenght of Pain in Conscious Multitrauma Patients, 0-14 Days After Multitrauma
- ClinicalTrials.gov ID
- NCT03730272
- Acronym / sponsor ID
- Trauma.pain.Gyda
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To register the perceived pain score during 0-14 days after multitrauma in conscious patients and to register the use (type and dose) of analgesic treatment in the same period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients With any kind of multitrauma, fullfilling inclusion/exclusion
Key inclusion criteria (1 listed)
- Patient With trauma, ISS > 8
Key exclusion criteria (4 listed)
- Unconscious patients at admission
- patients due for major surgery within 3 hrs of admission
- patients primary admitted to other hospitals
- not able to communicate in Norewegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analgesic drugs and methodsthe patient will receive analgesic treatment at the discretion of the physician in charge | Drug | – |
Primary outcome
Worst pain
Time frame: 0-14 days
NRS scale, 0-10
Average pain
Time frame: 0-14 days
NRS scale, 0-10
1 secondary outcome
analgesic methods
Time frame: 0-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Pain and Post Traumatic Analgesic Treatment, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst pain (time frame: 0-14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.