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
  Purpose

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 Intervention Phase
Knee Injuries
Drug: 1 Ketorolac intraarticular
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Pain relief local anti-flammatory effects [ Time Frame: 2 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rescue analgesic consumption [ Time Frame: 2 h ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ketorolac
Drug: 1 Ketorolac intraarticular
Ketorolac intraarticular 5 mg
Other Names:
  • Ketorolac
  • Saline
Placebo Comparator: 2
saline
Drug: Placebo
Saline

Detailed Description:

Randomizized controlled trial

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774540

Contacts
Contact: Leiv Arne Rosseland, PhD MD +47 23073000 leiv.arne.rosseland@rikshospitalet.no
Contact: Nina Solheim, MD +4723226424

Locations
Norway
Oslo University Hospital, Division of Emergencies and Critical Care Recruiting
Oslo, Norway, 0242
Contact: Leiv Arne Rosseland, PhD MD    23073700      
Contact: Nina Solheim, MD    +4723226424      
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Leiv Arne Rosseland Oslo University Hospital
  More Information

No publications provided

Responsible Party: Leiv Arne Rosseland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00774540     History of Changes
Other Study ID Numbers: Knemikro01, S-04342
Study First Received: October 16, 2008
Last Updated: November 6, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Acute pain
Inflammatory pain
Inflammatory mediators
Pain relief
Microdialysis

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Leg Injuries
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014