Occurence of Pain and Use of Analgesic Treatment in Multi... | NCT03730272

Studies
Occurence of Pain and Use of Analgesic Treatment in Multi-trauma Patients of Intermediate Seveity

NCT03730272

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Nov 5, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Post Traumatic Pain
Post Traumatic Analgesic Treatment

Interventions

analgesic drugs and methods

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Mar 2019Estimated

Completion Date

Nov 1, 2019Estimated

First Submitted Date

Nov 1, 2018

First Submission Date that Met QC Criteria

Nov 1, 2018

First Posted Date

Nov 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2018

Last Update Posted Date

Nov 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
analgesic drugs and methods	Drug	the patient will receive analgesic treatment at the discretion of the physician in charge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Worst pain	NRS scale, 0-10	0-14 days
Average pain	NRS scale, 0-10	0-14 days

Secondary Outcomes

Measure	Description	Time Frame
analgesic methods	list of drugs (dose and duration) and other analgesic measures	0-14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient With trauma, ISS > 8

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients With any kind of multitrauma, fullfilling inclusion/exclusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Anesthesiology, Oslo University Hospital, Ullevaal	Recruiting	Oslo		0407	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000700	Analgesics
D008722	Methods

Ancestor Terms

ID	Term
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided