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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21NR010929-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
| Jacobi Medical Center | OTHER |
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The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing regimens.
The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms:
All patients will receive a loading dose of 0.1 mg/kg morphine. All patients can receive additional analgesics as needed, at the discretion of the provider.
We hypothesize that morphine supplied via PCA will provide superior analgesia without a greater incidence of adverse events when compared to non-PCA pain management; and that PCA demand dosing of 1.5 mg will be superior to 1.0 mg without more adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-controlled analgesia 1 mg demand dose | Experimental | 0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes |
|
| Patient-controlled analgesia 1.5 mg demand dose | Experimental | 0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes |
|
| Non-Patient-controlled analgesia comparison group | Active Comparator | 0.1 mg/kg morphine loading dose plus additional analgesia as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-controlled analgesia | Device | Intravenous morphine delivered via Curlin painsmart PCA device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale | Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline. | Baseline and 30 minutes post treatment |
| Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Pain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief) | 30 minutes post treatment |
| Long Term Efficacy: Total Analgesia Provided Over 2 Hours | Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain Total analgesia is measured by a summary of change in pain that varies from 0 - no change to | Baseline, 30, 60, 90, 120 post-treatment |
| Long Term Efficacy: Pain Relief by 120 Minutes | Participants aksed to and give range | 120 minutes |
| Safety: Incidence of Adverse Events | Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Supplementary Analgesia | count of participants who needed or did not needed additional analgesia | 2 hours post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrienne J Birnbaum, MD, MS | Jacobi Medical Center, Albert Einstein College of Medicine | Principal Investigator |
| Polly E Bijur, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22506940 | Derived | Birnbaum A, Schechter C, Tufaro V, Touger R, Gallagher EJ, Bijur P. Efficacy of patient-controlled analgesia for patients with acute abdominal pain in the emergency department: a randomized trial. Acad Emerg Med. 2012 Apr;19(4):370-7. doi: 10.1111/j.1553-2712.2012.01322.x. |
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Recruitment started April 3, 2009 and ended June 30, 2010. Patients were recruited by bilingual research associates in the Emergency Department of Jacobi Medical Center, Bronx, NY
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| ID | Title | Description |
|---|---|---|
| FG000 | PCA 1 mg Demand Dose | 0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dose every 6 minutes Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device morphine: Intravenous morphine |
| FG001 | PCA 1.5 mg Demand Dose | 0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device morphine: Intravenous morphine |
| FG002 | Non-PCA Comparison Group | 0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain. morphine: Intravenous morphine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCA 1 mg Demand Dose | 0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device morphine: Intravenous morphine |
| BG001 | PCA 1.5 mg Demand Dose |
| 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 | Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale | Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline and 30 minutes post treatment |
|
Up to 8 hours
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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 | PCA 1 mg Demand Dose | 0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device morphine: Intravenous morphine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Oxygen Desaturation as measured by pulse oximetry | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | Systematic Assessment | Transient sluggish response to loud sound after also receiving lorazepam (non-study drug) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Polly Bijur, PhD | Albert Einstein College of Medicine | 718-430-4217 | polly.bijur@einstein.yu.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| D010323 | Passive Cutaneous Anaphylaxis |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
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|
| morphine | Drug | Intravenous morphine |
|
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device morphine: Intravenous morphine |
| BG002 | Non-PCA Comparison Group | 0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain. morphine: Intravenous morphine |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race and ethnicity were asked separately. As the majority of patients who identified their ethnicity as Hispanic/Latino did not specify a race, patients were categorized as Hispanic/Latino regardless of race. If patients were not Hispanic/Latino, they were categorized by race | Count of Participants | Participants |
|
| Initial Pain Score | Numerical rating scale (NRS) of pain: 0 indicates no pain, 10 indicates worst possible pain | Count of Participants | Participants |
|
| OG001 | PCA 1.5 mg Demand Dose | 0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device morphine: Intravenous morphine |
| OG002 | Non-PCA Comparison Group | 0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain. morphine: Intravenous morphine |
|
|
|
| Primary | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Pain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief) | Posted | Count of Participants | Participants | 30 minutes post treatment |
|
|
|
|
| Primary | Long Term Efficacy: Total Analgesia Provided Over 2 Hours | Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain Total analgesia is measured by a summary of change in pain that varies from 0 - no change to | Posted | Mean | 95% Confidence Interval | scores on a scale *minutes | Baseline, 30, 60, 90, 120 post-treatment |
|
|
|
|
| Primary | Long Term Efficacy: Pain Relief by 120 Minutes | Participants aksed to and give range | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
|
| Primary | Safety: Incidence of Adverse Events | Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg) | Posted | Count of Participants | Participants | 2 hours |
|
|
|
|
| Secondary | Need for Supplementary Analgesia | count of participants who needed or did not needed additional analgesia | Posted | Count of Participants | Participants | 2 hours post treatment |
|
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 1 |
| 67 |
| EG001 | PCA 1.5 mg Demand Dose | 0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device morphine: Intravenous morphine | 0 | 70 | 1 | 70 | 0 | 70 |
| EG002 | Non-PCA Comparison Group | 0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain. morphine: Intravenous morphine | 0 | 69 | 1 | 69 | 0 | 69 |
| Transient decrease in blood pressure | Cardiac disorders | Systematic Assessment |
|
|
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| 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 |
| Title | Measurements |
|---|---|
|
| Moderate relief |
|
| A lot of relief |
|
| Complete relief |
|
| Title | Measurements |
|---|---|
|
| Moderate relief |
|
| A lot of relief |
|
| Complete relief |
|
|
|