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No participants were enrolled and the study will not be conducted.
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The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.
To perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.. The 2 groups are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone/acetaminophen | Active Comparator | Oxycodone/acetaminophen (5 mg/325 mg) |
|
| Ibuprofen/acetaminophen | Active Comparator | Ibuprofen/acetaminophen (400 mg/500 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone/acetaminophen | Drug | Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Between group difference in change in NRS pain scores | Between group difference in change in NRS pain scores at 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Between group difference in change in NRS pain scores at first followup contact | Between group difference in change in NRS pain scores at first followup contact | 24-72 hours |
| Between group difference in change in NRS pain scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical College | Albany | New York | 12208 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen/acetaminophen | Drug | Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen |
|
Between group difference in change in NRS pain scores at 48 hours and 72 hours
| 48 hours and 72 hours |
| Between group difference in side effects | Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation) | 24 hours, 48 hours and 72 hours |
| Change in NRS pre and 2 hours post most recent dose of pain medication taken | Change in NRS pre and 2 hours post most recent dose of pain medication taken | 24 hours |
| Between group difference in Likert pain scores | Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe) | 24, 48, and 72 hours |
| Satisfaction | Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied | 24, 48, and 72 hours |
| Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain. | Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain. | 24-72 hours |
| Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to | Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to | 24-72 hours |
| Want same medication again | Between group difference in proportion of patients who would want the same medication again | 24-72 hours |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |