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The purpose of the current study is to compare the analgesic efficacy of intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ED.
This is a randomized, double-blind placebo-controlled clinical trial comparing intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the Emergency Department. Enrolled subjects presenting to the ED with acute pain will be randomized to receive either acetaminophen 1g IV or hydromorphone 1mg IV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator |
| |
| Hydromorphone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen 1g IV |
| |
| Hydromorphone |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Change at 60 minutes | Between group difference in change in NRS pain scores from baseline | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Forego Additional Pain Medication | Difference in proportion of patients who choose to forego additional pain medication | 60 minutes |
| Receive Rescue Medication | Difference in proportion of patients who receive additional pain medication before primary outcome |
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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 |
|---|---|---|---|
| 30119941 | Derived | Barnaby DP, Chertoff AE, Restivo AJ, Campbell CM, Pearlman S, White D, Bijur PE, Gallagher EJ. Randomized Controlled Trial of Intravenous Acetaminophen Versus Intravenous Hydromorphone for the Treatment of Acute Pain in the Emergency Department. Ann Emerg Med. 2019 Feb;73(2):133-140. doi: 10.1016/j.annemergmed.2018.06.019. Epub 2018 Aug 14. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2020 | Mar 16, 2020 | 3 | ||
| Apr 30, 2021 |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
Hydromorphone 1mg IV |
|
| Before 60 minutes |
| Experience Medication Side Effects | Difference in proportion of patients who experience medication side effects grouped by GI (vomiting, nausea), dermatologic (pruritis, rash), and CNS (dizziness, drowsiness) categories. | 120 Minutes |
| May 21, 2021 |
| 4 |
| Jun 3, 2021 | Jun 23, 2021 | 5 |
| Jul 13, 2021 | Aug 3, 2021 | 6 |
| Aug 25, 2021 | Sep 21, 2021 | 7 |
| Oct 23, 2021 | Oct 31, 2021 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |