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Acute Pain and Inflammation After Surgery (Knemikro01)

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ClinicalTrials.gov Identifier: NCT00774540
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital

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

Detailed Description:
Randomizized controlled trial

Study Type : Interventional  (Clinical Trial)
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 : August 2008
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Pain relief local anti-flammatory effects [ Time Frame: 2 h ]

Secondary Outcome Measures :
  1. Rescue analgesic consumption [ Time Frame: 2 h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774540


Locations
Norway
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

Responsible Party: Leiv Arne Rosseland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00774540     History of Changes
Other Study ID Numbers: Knemikro01
S-04342
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by Leiv Arne Rosseland, Oslo University Hospital:
Acute pain
Inflammatory pain
Inflammatory mediators
Pain relief
Microdialysis

Additional relevant MeSH terms:
Acute Pain
Knee Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Leg Injuries
Wounds and Injuries
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action