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Trial record 82 of 463 for:    KETOROLAC

A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT00868348
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Pain
Interventions Drug: Ketorolac
Drug: Saline
Enrollment 60
Recruitment Details A total of 361 patients were assessed for eligibility from May 2009 through March 2011; 62 patients participated in another study, 54 patients declined to participate, and 185 patients were excluded based on the exclusion criteria. Sixty patients (30 in each group)were enrolled, and data for the primary endpoint were registered in all patients
Pre-assignment Details  
Arm/Group Title Control Ketorolac
Hide Arm/Group Description Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Control Ketorolac Total
Hide Arm/Group Description Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
Gender, Age,
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  36.7%
8
  26.7%
19
  31.7%
>=65 years
19
  63.3%
22
  73.3%
41
  68.3%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
71
(61 to 75)
70
(65 to 75)
71
(63 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
19
  63.3%
13
  43.3%
32
  53.3%
Male
11
  36.7%
17
  56.7%
28
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Morphine Consumption
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketorolac
Hide Arm/Group Description:
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Overall Number of Participants Analyzed 30 30
Median (Inter-Quartile Range)
Unit of Measure: mg
48.75
(30 to 82.2)
10
(0 to 22.5)
2.Secondary Outcome
Title Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request
Hide Description [Not Specified]
Time Frame within 48 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketorolac
Hide Arm/Group Description:
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Overall Number of Participants Analyzed 30 30
Median (Inter-Quartile Range)
Unit of Measure: min
223
(115 to 319)
490
(248 to 617)
3.Secondary Outcome
Title Pain Intensity Scores During Walking
Hide Description Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Time Frame 6-24 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketorolac
Hide Arm/Group Description:
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Overall Number of Participants Analyzed 30 30
Median (Inter-Quartile Range)
Unit of Measure: mm
64
(51 to 80)
29
(5 to 47)
4.Secondary Outcome
Title Home Readiness
Hide Description Ability to meet discharge criteria (home readiness)
Time Frame time to fulfilment of discharge criteria
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketorolac
Hide Arm/Group Description:
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Overall Number of Participants Analyzed 30 30
Median (Inter-Quartile Range)
Unit of Measure: days
3
(2 to 3)
2
(2 to 3)
5.Secondary Outcome
Title Length of Hospital Stay
Hide Description [Not Specified]
Time Frame From the day of surgery until discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketorolac
Hide Arm/Group Description:
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Overall Number of Participants Analyzed 30 30
Median (Inter-Quartile Range)
Unit of Measure: days
3
(3 to 3)
3
(2 to 3)
6.Secondary Outcome
Title Pain Intensity During Daily Activity
Hide Description Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Time Frame 16 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketorolac
Hide Arm/Group Description:
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Overall Number of Participants Analyzed 28 29
Median (Inter-Quartile Range)
Unit of Measure: mm
4
(1 to 21)
3
(3 to 12)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Ketorolac
Hide Arm/Group Description Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
All-Cause Mortality
Control Ketorolac
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Ketorolac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      2/30 (6.67%)    
Blood and lymphatic system disorders     
Haematoma [1]  0/30 (0.00%)  0 1/30 (3.33%)  1
Cardiac disorders     
tachycardia [2]  0/30 (0.00%)  0 1/30 (3.33%)  1
[1]
re-admission due haematoma
[2]
Know tachycardia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Ketorolac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Karen V Andersen
Organization: Aarhus University Hospital
Phone: 51263173 ext 0045
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00868348     History of Changes
Other Study ID Numbers: 2008-003180-39
First Submitted: March 24, 2009
First Posted: March 25, 2009
Results First Submitted: July 10, 2013
Results First Posted: March 10, 2014
Last Update Posted: March 10, 2014