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| ID | Type | Description | Link |
|---|---|---|---|
| 7K23AG033100-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.
A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV acetaminophen + 0.5 mg IV hydromorphone | Experimental | 1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone |
|
| Normal saline + 0.5 mg IV hydromorphone | Placebo Comparator | 100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV acetaminophen + 0.5 mg IV hydromorphone | Drug | 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused | Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given. | baseline and 60 minutes after medication was infused |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity Over Time | Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)]. Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Chang, MD, MS | Albany Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center Moses Division Emergency Department | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Acetaminophen + 0.5 mg IV Hydromorphone | 1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone 0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone |
| FG001 | Placebo + 0.5 mg IV Hydromorphone | 100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone 0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Acetaminophen + 0.5 mg IV Hydromorphone | 1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone 0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused | Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given. | Posted | Mean | Standard Deviation | units on a scale | baseline and 60 minutes after medication was infused |
|
60 minutes
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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 | IV Acetaminophen + 0.5 mg IV Hydromorphone | 1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone 0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Only includes patients who were neither nauseated or vomiting before receiving study medication. Those with symptoms before medication infusion were not experiencing the symptom as a side effect, and were therefore not included |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Chang | Albany Medical Center | 518-262-0042 | changa1@amc.edu |
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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 | Feb 5, 2016 | Sep 2, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000377 | Agnosia |
| 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 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Normal saline + 0.5 mg IV hydromorphone | Drug | 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone |
|
|
| baseline to 5 min, 15 min, 30 min, and 45 minutes |
| Placebo + 0.5 mg IV Hydromorphone |
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone 0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone |
| BG002 | 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 |
|
| Baseline Pain intensity | Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). This baseline measure indicates the number of participants reporting a given NRS score. | Count of Participants | Participants |
|
| Number of patients nauseated before receiving study medication | Number of patients nauseated due to their condition, whether as a symptom on its own or due to their level of pain. Those experiencing nausea or vomiting at baseline would not be counted with those who experience nausea or vomiting as a side effect of study medication when comparing the effects and side effects of the study medication. | Count of Participants | Participants |
|
| Number of patients vomited before receiving study medication | Number of patients vomiting due to their condition, whether as a symptom on its own or due to their level of pain. Those experiencing nausea or vomiting at baseline would not be counted with those who experience nausea or vomiting as a side effect of study medication when comparing the effects and side effects of the study medication. | Count of Participants | Participants |
|
| OG001 | Placebo + 0.5 mg IV Hydromorphone | 100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone 0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone |
|
|
| Secondary | Change in Pain Intensity Over Time | Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)]. Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes | Posted | Mean | Standard Deviation | units on a scale | baseline to 5 min, 15 min, 30 min, and 45 minutes |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 16 |
| 80 |
| EG001 | Placebo + 0.5 mg IV Hydromorphone | 100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone 0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone | 0 | 79 | 0 | 79 | 13 | 79 |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Only includes patients who were neither nauseated or vomiting before receiving study medication. Those with symptoms before medication infusion were not experiencing the symptom as a side effect, and were therefore not included |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Heart rate < 50 beats/min | Cardiac disorders | Systematic Assessment |
|
| Oxygen saturation < 95% | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Systolic blood pressure < 90 mmHg | Vascular disorders | Systematic Assessment |
|
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| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Baseline to 30 minutes |
|
| Baseline to 45 minutes |
|