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| Name | Class |
|---|---|
| Pharmbio Korea | UNKNOWN |
This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.
The balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. Previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. We hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Sequential intravenous administration of ketorolac and nefopam |
|
| Group 2 | Active Comparator | Sequential intravenous administration of ketorolac and morphine |
|
| Group 3 | Placebo Comparator | Intravenous administration of ketorolac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac and nefopam balanced analgesia | Drug | Sequential intravenous administration of ketorolac and nefopam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of pain reduction by visual analog pain scale | At 30 and 60 minutes after primary study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Additional analgesia requested by enrolled patients | At 30 and 60 minutes after primary study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyuseok Kim, MD | Contact | 82-31-787-3049 | dremkks@snubh.org | |
| Joonghee Kim, MD | Contact | 82-10-9489-3696 | joonghee@me.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Kyeongi-do | South Korea |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D009020 | Morphine |
| D000698 | Analgesia |
| D000700 | Analgesics |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Balanced analgesia using ketorolac and morphine | Drug | Sequential intravenous administration of ketorolac and morphine |
|
| Pain control with single analgesics (ketorolac) | Drug | This arm do not use balanced analgesia. Instead, ketorolac IV administration followed by 50cc normal saline administration (for blinding) will be used in this group. |
|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000760 | Anesthesia and Analgesia |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |