Back to resultsA Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ketorolac
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Total knee arthroplasty
- Age > 18
- Tolerance for study drugs
- Written informed consent
Exclusion Criteria:
-
Sites / Locations
- Aarhus University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Saline
Ketorolac
Arm Description
Outcomes
Primary Outcome Measures
Morphine Consumption
Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery
Secondary Outcome Measures
Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request
Pain Intensity Scores During Walking
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Home Readiness
Ability to meet discharge criteria (home readiness)
Length of Hospital Stay
Pain Intensity During Daily Activity
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00868348
Brief Title
A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty
Official Title
Local Infiltration Analgesia for Total Knee Arthroplasty: Should Ketorolac be Added
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Title
Ketorolac
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
1 ml infiltration 4 ml intraarticular bolus injection of placebo
Primary Outcome Measure Information:
Title
Morphine Consumption
Description
Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request
Time Frame
within 48 hours after surgery
Title
Pain Intensity Scores During Walking
Description
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Time Frame
6-24 hours postoperatively
Title
Home Readiness
Description
Ability to meet discharge criteria (home readiness)
Time Frame
time to fulfilment of discharge criteria
Title
Length of Hospital Stay
Time Frame
From the day of surgery until discharge
Title
Pain Intensity During Daily Activity
Description
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Time Frame
16 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Total knee arthroplasty
Age > 18
Tolerance for study drugs
Written informed consent
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjels Søballe, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty
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