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Acute Pain and Inflammation After Surgery (Knemikro01)

Primary Purpose

Knee Injuries

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
1 Ketorolac intraarticular
Placebo
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring Acute pain, Inflammatory pain, Inflammatory mediators, Pain relief, Microdialysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Oslo University Hospital, Division of Emergencies and Critical Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Ketorolac

saline

Outcomes

Primary Outcome Measures

Pain relief local anti-flammatory effects

Secondary Outcome Measures

Rescue analgesic consumption

Full Information

First Posted
October 16, 2008
Last Updated
April 22, 2015
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00774540
Brief Title
Acute Pain and Inflammation After Surgery
Acronym
Knemikro01
Official Title
Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to observe acute pain after surgery and measure the natural course of inflammatory mediators study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac
Detailed Description
Randomizized controlled trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
Acute pain, Inflammatory pain, Inflammatory mediators, Pain relief, Microdialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ketorolac
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
saline
Intervention Type
Drug
Intervention Name(s)
1 Ketorolac intraarticular
Other Intervention Name(s)
Ketorolac, Saline
Intervention Description
Ketorolac intraarticular 5 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Pain relief local anti-flammatory effects
Time Frame
2 h
Secondary Outcome Measure Information:
Title
Rescue analgesic consumption
Time Frame
2 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Day case surgical patients above 18 years old Non pregnant Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leiv Arne Rosseland
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Division of Emergencies and Critical Care
City
Oslo
ZIP/Postal Code
0242
Country
Norway

12. IPD Sharing Statement

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Acute Pain and Inflammation After Surgery

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