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NCT00774540 Clinical Trial

Acute Pain and Inflammation After Surgery

Knee Injuries Clinical Trial

— Knemikro01  

Official title:
Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00774540
Other study ID # Knemikro01
Secondary ID S-04342
Status Completed
Phase Phase 4
First received October 16, 2008
Last updated April 22, 2015
Start date August 2008
Est. completion date December 2014

Study information
Verified date April 2015
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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

Description:

Randomizized controlled trial

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Day case surgical patients above 18 years old

- Non pregnant

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 1 Ketorolac intraarticular
Ketorolac intraarticular 5 mg
• Placebo
Saline

Locations
Country Name City State
Norway Oslo University Hospital, Division of Emergencies and Critical Care Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain relief local anti-flammatory effects 2 h No
Secondary Rescue analgesic consumption 2 h Yes
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