Acute Pain and Inflammation After Surgery (Knemikro01)

This study has been completed.
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital Identifier:
First received: October 16, 2008
Last updated: April 22, 2015
Last verified: April 2015

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 ]

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

Detailed Description:
Randomizized controlled trial

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

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00774540

Oslo University Hospital, Division of Emergencies and Critical Care
Oslo, Norway, 0242
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Leiv Arne Rosseland Oslo University Hospital
  More Information

Responsible Party: Leiv Arne Rosseland, Professor, Oslo University Hospital Identifier: NCT00774540     History of Changes
Other Study ID Numbers: Knemikro01  S-04342 
Study First Received: October 16, 2008
Last Updated: April 22, 2015
Health Authority: Norway: Norwegian Medicines Agency

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

Additional relevant MeSH terms:
Acute Pain
Knee Injuries
Leg Injuries
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Ketorolac Tromethamine
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016