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Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen 1000mg IV | Experimental | NRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes. |
|
| Hydromorphone 0.5mg IV | Active Comparator | NRS pain score will be checked at 5 minutes and every 15 minutes thereafter for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen 1000mg IV | Drug | 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement in NRS Pain Score | Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale. | 60 minutes following administration of medication |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Rescue Medication | Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course. | 120 minutes following administration of medication |
| Improvement in NPS Pain Score by >=50% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Friedman, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35965162 | Derived | Kolli S, Friedman BW, Latev A, Chang AK, Naeem F, Feliciano C, Afrifa F, Walker C, Izzo A, Irizarry E. A Randomized Study of Intravenous Hydromorphone Versus Intravenous Acetaminophen for Older Adult Patients with Acute Severe Pain. Ann Emerg Med. 2022 Nov;80(5):432-439. doi: 10.1016/j.annemergmed.2022.06.016. Epub 2022 Aug 12. |
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Enrollment began in August 2018, paused between March and June 2020, and concluded in October 2021. A total of 2,363 patients were screened for participation of which 162 were enrolled from two urban emergency departments in Bronx, NY.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen 1000mg IV | Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push. |
| FG001 | Hydromorphone 0.5mg IV | Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen 1000mg IV | Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push. |
| BG001 | Hydromorphone 0.5mg IV |
| 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 | Clinical Improvement in NRS Pain Score | Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale. | Posted | Count of Participants | Participants | 60 minutes following administration of medication |
|
Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
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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 | Acetaminophen 1000mg IV | Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
Enrollment limited to 2 urban EDs, excluding a large number of patients who had been screened. Results may not be generalizable to all older patients with acute severe pain Dose ranging studies were not conducted to help optimize hydromorphone dosage An arbitrary value (1.3) was selected as the minimum clinically important improvement threshold The study relied on the clinical attending physician's judgment of whether opioids were indicated. Would not account for local practices
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Friedman | Montefiore Medical Center | 718-920-6626 | bfriedm@montefiore.org |
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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 | Jul 17, 2018 | Dec 29, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| 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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| Hydromorphone 0.5 mg IV | Drug | 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push |
|
The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.
| 60 minutes after administration of medication |
Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Pain | Median | Inter-Quartile Range | Minutes |
|
| NRS Pain Score (0-10) | Pain intensity was assessed at baseline using an NRS (numeric rating scale) to assess participants' pain on a linear range of 0-10. Participants were asked to verbalize level of pain on a scale where 0 represented "no pain" and 10 represented "the worst pain imaginable." As such, a higher NRS baseline pain score denoted a higher degree of pain being felt prior to treatment. | Median | Inter-Quartile Range | score on a scale |
|
| Location of Pain | Count of Participants | Participants |
|
| Hydromorphone 0.5mg IV |
Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push. |
|
|
| Secondary | Need for Rescue Medication | Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course. | Study participants did not receive any additional medication before the assessment of the primary outcome. | Posted | Count of Participants | Participants | 120 minutes following administration of medication |
|
|
|
| Secondary | Improvement in NPS Pain Score by >=50% | The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes. | Study participants did not receive any additional medication before the assessment of the primary outcome. | Posted | Count of Participants | Participants | 60 minutes after administration of medication |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 6 |
| 81 |
| EG001 | Hydromorphone 0.5mg IV | Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push. | 0 | 81 | 0 | 81 | 10 | 81 |
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Discomfort NEC | General disorders | Non-systematic Assessment | NEC - not elsewhere classified |
|
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| 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 |