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The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.
To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone/acetaminophen | Active Comparator | Oxycodone/acetaminophen (5 mg/325 mg) |
|
| Hydrocodone/acetaminophen | Active Comparator | Hydrocodone/acetaminophen (5 mg/300 mg) |
|
| Codeine/acetaminophen | Active Comparator | Codeine/acetaminophen (30 mg/300 mg) |
|
| Ibuprofen/acetaminophen | Active Comparator | Ibuprofen/acetaminophen (400 mg/1000 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone/acetaminophen | Drug |
|
| |
| Hydrocodone/acetaminophen |
| Measure | Description | Time Frame |
|---|---|---|
| Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29114833 | Derived | Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxycodone/Acetaminophen | Oxycodone/acetaminophen (5 mg/325 mg) Oxycodone/acetaminophen |
| FG001 | Hydrocodone/Acetaminophen | Hydrocodone/acetaminophen (5 mg/300 mg) Hydrocodone/acetaminophen |
| FG002 | Codeine/Acetaminophen | Codeine/acetaminophen (30 mg/300 mg) Codeine/acetaminophen |
| FG003 | Ibuprofen/Acetaminophen | Ibuprofen/acetaminophen (400 mg/1000 mg) Ibuprofen/acetaminophen |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodone/Acetaminophen | Oxycodone/acetaminophen (5 mg/325 mg) Oxycodone/acetaminophen |
| BG001 | Hydrocodone/Acetaminophen | Hydrocodone/acetaminophen (5 mg/300 mg) Hydrocodone/acetaminophen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) | Posted | Number | 95% Confidence Interval | units on a scale | 2 hours |
|
Adverse events were not collected
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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 | Oxycodone/Acetaminophen | Oxycodone/acetaminophen (5 mg/325 mg) Oxycodone/acetaminophen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Chang | Albany Medical College | 2125555555 | achang3@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2015 | Feb 7, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 27, 2015 | Feb 7, 2018 | ICF_001.pdf |
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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 |
| C526278 | acetaminophen, codeine drug combination |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
|
|
| Codeine/acetaminophen | Drug |
|
|
| Ibuprofen/acetaminophen | Drug |
|
| BG002 | Codeine/Acetaminophen | Codeine/acetaminophen (30 mg/300 mg) Codeine/acetaminophen |
| BG003 | Ibuprofen/Acetaminophen | Ibuprofen/acetaminophen (400 mg/1000 mg) Ibuprofen/acetaminophen |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Codeine/Acetaminophen |
Codeine/acetaminophen (30 mg/300 mg) Codeine/acetaminophen |
| OG003 | Ibuprofen/Acetaminophen | Ibuprofen/acetaminophen (400 mg/1000 mg) Ibuprofen/acetaminophen |
|
|
| Secondary | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) | Posted | Number | 95% Confidence Interval | units on a scale | 1 hour |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Hydrocodone/Acetaminophen | Hydrocodone/acetaminophen (5 mg/300 mg) Hydrocodone/acetaminophen | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Codeine/Acetaminophen | Codeine/acetaminophen (30 mg/300 mg) Codeine/acetaminophen | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Ibuprofen/Acetaminophen | Ibuprofen/acetaminophen (400 mg/1000 mg) Ibuprofen/acetaminophen | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |