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The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.
The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department. We hypothesize that the combination will be more effective than either agent alone in patients presenting to the emergency department with acute pain from musculoskeletal injuries such as sprain, and bruises. While each agent alone is effective to some degree, many patients do not find complete relief with them and often narcotic agents (with all of their potential side effects) are added. In this study patients experiencing any pain will be randomly given either ibuprofen OR acetaminophen OR their combination and their degree of pain severity will be measured every 15 minutes up to one hour. At the end of this 1 hour patients still experiencing pain and requiring additional pain relief will receive additional analgesics at the discretion of their treating physician. We will not only measure how much the pain severity was reduced but also the percentage of patients that require some form of additional or "rescue" medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Active Comparator | Ibuprofen 800 mg |
|
| Acetaminophen | Active Comparator | Acetaminophen 1 gm |
|
| Ibuprofen-acetaminophen combination | Experimental | Ibuprofen 800 mg plus acetaminophen 1 gm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | single dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity | Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Rescue Pain Relief | The need for additional analgesics | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam J Singer, MD | Stony Brook University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32797734 | Derived | Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3. |
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Patients were recruited from the emergency department over a 1 year period
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen | Ibuprofen 800 mg |
| FG001 | Acetaminophen | Acetaminophen 1 gm |
| FG002 | Ibuprofen-acetaminophen Combination | Ibuprofen 800 mg plus acetaminophen 1 gm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | Ibuprofen 800 mg |
| BG001 | Acetaminophen | Acetaminophen 1 gm |
| BG002 |
| 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 | Pain Severity | Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain) | Posted | Mean | 95% Confidence Interval | mm | 1 hour |
|
7 days
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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 | Ibuprofen | Ibuprofen 800 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
Small sample size, single center, short follow up
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Singer | Emergency Medicine, Stony Brook U | 631 444 7856 | adam.singer@stonybrook.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Acetaminophen |
| Drug |
single dose |
|
|
| Ibuprofen-acetaminophen combination | Drug | single dose |
|
|
| Ibuprofen-acetaminophen Combination |
Ibuprofen 800 mg plus acetaminophen 1 gm |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Need for Rescue Pain Relief | The need for additional analgesics | Posted | Number | participants | 1 hour |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Acetaminophen | Acetaminophen 1 gm | 0 | 30 | 0 | 30 |
| EG002 | Ibuprofen-acetaminophen Combination | Ibuprofen 800 mg plus acetaminophen 1 gm | 0 | 30 | 1 | 30 |
| Nausea | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
|
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| D009140 | Musculoskeletal Diseases |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |