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

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ClinicalTrials.gov Identifier: NCT03730272
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Johan C Ræder, Oslo University Hospital

Tracking Information
First Submitted Date November 1, 2018
First Posted Date November 5, 2018
Last Update Posted Date November 5, 2018
Actual Study Start Date August 1, 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2018)
  • Worst pain [ Time Frame: 0-14 days ]
    NRS scale, 0-10
  • Average pain [ Time Frame: 0-14 days ]
    NRS scale, 0-10
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 1, 2018)
analgesic methods [ Time Frame: 0-14 days ]
list of drugs (dose and duration) and other analgesic measures
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Occurence of Pain and Use of Analgesic Treatment in Multi-trauma Patients of Intermediate Seveity
Official Title The Incidence and Strenght of Pain in Conscious Multitrauma Patients, 0-14 Days After Multitrauma
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients With any kind of multitrauma, fullfilling inclusion/exclusion
Condition
  • Post Traumatic Pain
  • Post Traumatic Analgesic Treatment
Intervention Drug: analgesic drugs and methods
the patient will receive analgesic treatment at the discretion of the physician in charge
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 1, 2018)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03730272
Other Study ID Numbers Trauma.pain.Gyda
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johan C Ræder, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Oslo University Hospital
Verification Date November 2018