Clincosm LogoSign in Get a demo

Knemikro01: Acute Pain and Inflammation After Surgery

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00774540
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
76
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is

  1. to observe acute pain after surgery and measure the natural course of inflammatory mediators

  2. study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac

Condition or Disease Intervention/Treatment Phase
  • Drug: 1 Ketorolac intraarticular
  • Drug: Placebo
 Phase 4

Detailed Description

Randomizized controlled trial

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Ketorolac

Drug: 1 Ketorolac intraarticular
Ketorolac intraarticular 5 mg
Other Names:
  • Ketorolac
  • Saline

    		•
    Placebo Comparator: 2

    saline

    Drug: Placebo
    Saline

    Outcome Measures

    Primary Outcome Measures

    1. Pain relief local anti-flammatory effects [2 h]

    Secondary Outcome Measures

    1. Rescue analgesic consumption [2 h]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Day case surgical patients above 18 years old

    • Non pregnant

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo University Hospital, Division of Emergencies and Critical Care Oslo Norway 0242

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    • Principal Investigator: Leiv Arne Rosseland, Oslo University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leiv Arne Rosseland, Professor, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT00774540
    Other Study ID Numbers:
    • Knemikro01
    • S-04342
    First Posted:
    Oct 17, 2008
    Last Update Posted:
    Apr 23, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Leiv Arne Rosseland, Professor, Oslo University Hospital
    Acute pain
    Inflammatory pain
    Inflammatory mediators
    Pain relief
    Microdialysis
    Additional relevant MeSH terms:
    Acute Pain
    Knee Injuries
    Ketorolac
    Ketorolac Tromethamine

    Study Results

    No Results Posted as of Apr 23, 2015