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The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator |
| |
| Ketorolac | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | 30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Consumption | Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request | within 48 hours after surgery | |
| Pain Intensity Scores During Walking | Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible) |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Kjels Søballe, Professor | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Aarhus | 8000 | Denmark |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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 |
| FG001 | Ketorolac | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Gender, Age,
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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 |
| BG001 | Ketorolac |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Consumption | Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery | Posted | Median | Inter-Quartile Range | mg | 48 hours after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Blood and lymphatic system disorders | re-admission due haematoma |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen V Andersen | Aarhus University Hospital | 51263173 | 0045 | karenand@rm.dk |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Saline | Drug | 1 ml infiltration 4 ml intraarticular bolus injection of placebo |
|
| 6-24 hours postoperatively |
| Home Readiness | Ability to meet discharge criteria (home readiness) | time to fulfilment of discharge criteria |
| Length of Hospital Stay | From the day of surgery until discharge |
| Pain Intensity During Daily Activity | Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible) | 16 weeks after surgery |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request | Posted | Median | Inter-Quartile Range | min | within 48 hours after surgery |
|
|
|
| Secondary | Pain Intensity Scores During Walking | Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible) | Posted | Median | Inter-Quartile Range | mm | 6-24 hours postoperatively |
|
|
|
| Secondary | Home Readiness | Ability to meet discharge criteria (home readiness) | Posted | Median | Inter-Quartile Range | days | time to fulfilment of discharge criteria |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Median | Inter-Quartile Range | days | From the day of surgery until discharge |
|
|
|
| Secondary | Pain Intensity During Daily Activity | Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible) | Posted | Median | Inter-Quartile Range | mm | 16 weeks after surgery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Ketorolac | 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 | 2 | 30 | 0 | 30 |
| tachycardia | Cardiac disorders | Know tachycardia |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |