Acute Pain and Inflammation After Surgery (Knemikro01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00774540
First received: October 16, 2008
Last updated: November 6, 2013
Last verified: November 2013

October 16, 2008
November 6, 2013
August 2008
March 2014   (final data collection date for primary outcome measure)
Pain relief local anti-flammatory effects [ Time Frame: 2 h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00774540 on ClinicalTrials.gov Archive Site
Rescue analgesic consumption [ Time Frame: 2 h ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Acute Pain and Inflammation After Surgery
Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis

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

Randomizized controlled trial

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Knee Injuries
  • Drug: 1 Ketorolac intraarticular
    Ketorolac intraarticular 5 mg
    Other Names:
    • Ketorolac
    • Saline
  • Drug: Placebo
    Saline
  • Experimental: 1
    Ketorolac
    Intervention: Drug: 1 Ketorolac intraarticular
  • Placebo Comparator: 2
    saline
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Day case surgical patients above 18 years old
  • Non pregnant

Exclusion Criteria:

-

Both
18 Years to 75 Years
No
Contact: Leiv Arne Rosseland, PhD MD +47 23073000 leiv.arne.rosseland@rikshospitalet.no
Contact: Nina Solheim, MD +4723226424
Norway
 
NCT00774540
Knemikro01, S-04342
Yes
Leiv Arne Rosseland, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Leiv Arne Rosseland Oslo University Hospital
Oslo University Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP