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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR013980 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Jacobi Medical Center | OTHER |
| Montefiore Medical Center | OTHER |
| University of Pennsylvania | OTHER |
| National Institute of Nursing Research (NINR) |
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Background: Inadequate pain management is common in the Emergency Department (ED). Optimal treatment of pain necessitates titration to effective dose due to the large inter-individual variability in opioid requirement. However nurse administered titration is difficult to provide in this setting due to high patient to nurse and physician ratios and multiple urgent competing patient demands. Patient controlled analgesia (PCA) lets ED patients actively participate in pain management by allowing self-titration to their desired level of pain relief. A tightly controlled randomized clinical trial (RCT) funded by the National Institute of Nursing Research (NINR) recently completed by the investigators group provides promising preliminary support for the efficacy and safety of PCA for patients with abdominal pain at a single ED with a dedicated research nurse and standard loading dose given to all patients. Objective: The overall objective is to provide optimal pain management in the ED. Specific aims: 1)To compare the effectiveness and safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver the intervention to a broad group of ED patients with acute pain at multiple clinical centers. The primary hypothesis is that there will be a greater decline in pain over time and similar safety in patients randomized to receive PCA compared to patients receiving standard opioid analgesia. 2) To describe the feasibility of PCA in terms of patient and provider acceptance, resource utilization and cost associated with PCA. Innovation: PCA represents a novel shift from the current provider-driven model of ED pain management to one in which the patient is an active participant. Few prior studies have evaluated ED PCA and no systematic evaluation of time and resources exists. Methodology: An RCT will be performed at 3 clinical centers. 750 patients with acute pain warranting IV opioid administration will be randomized to receive usual opioid analgesia determined by the provider or PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes). Pain intensity will be measured by a numerical rating scale (NRS) recorded every half hour up to 2 hours after initial opioid administration. Primary endpoints are rate of change in pain intensity from 30 minutes after initial administration of opioid to 2 hours as suggested by the results of the preliminary study and incidence of adverse events. PCA will also be compared to non-PCA opioid analgesia assessed at the end of the 2 hour study period by patient satisfaction with pain management; registered nurse (RN) assessment of time efficiency/ease of use and satisfaction with pain management; and physician satisfaction with pain management. Resource utilization and cost associated with implementation and use of PCA in the ED setting will be assessed by total Registered nurse (RN) time spent on pain management per patient; pharmacy preparation time per patient; material cost per patient and Registered Nurse and Physician training time necessary for PCA implementation. Significance: If PCA is demonstrated to be effective, safe, and associated with patient and provider acceptance and acceptable resource utilization, it has the potential to significantly improve ED pain management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Controlled Analgesia | Experimental | PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) |
|
| Usual Care | Active Comparator | Usual opioid analgesia determined by the provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient controlled analgesia (PCA) | Device | Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Change in Pain Intensity Per Hour | Rate of Change in Numerical Rating Scale (NRS) of Pain per hour where 0 indicates "no pain", 10 indicates "worst possible pain" between 30 minutes and 120 minutes post-baseline i.e. NRS at 30 minutes minus NRS at 120 minutes post-baseline. | 1.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events | Number of participants with one or more adverse events defined by: oxygen saturation measured by pulse oximetry < 92% for one minute or more, respiratory rate <10 breaths/min counted for 60 seconds, or systolic blood pressure < 90 mm Hg. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Nurse Preference for PCA or Conventional Administration of IV Opioids | Single question about preference for PCA versus preference for conventional administration of IV opioids. | 2 hours |
| Physician Preference for PCA or Usual Care |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Polly Bijur, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Adrienne Birnbaum, MD | Jacobi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States | ||
| Montefiore Medical Center - Moses Division |
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Recruitment occurred from April 30, 2013 through February 25, 2016 in the Emergency Departments of three medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Controlled Analgesia | PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes |
| FG001 | Usual Care | Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Controlled Analgesia | PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Rate of Change in Pain Intensity Per Hour | Rate of Change in Numerical Rating Scale (NRS) of Pain per hour where 0 indicates "no pain", 10 indicates "worst possible pain" between 30 minutes and 120 minutes post-baseline i.e. NRS at 30 minutes minus NRS at 120 minutes post-baseline. | All patients enrolled | Posted | Mean | 95% Confidence Interval | Score on a scale per hour | 1.5 hours |
|
2 hours
Need for oxygen supplementation or ventilatory assistance Hypotension requiring fluid administration or vasopressors Administration of naloxone (an opioid reversal agent) Oxygen saturation measured by pulse oximetry < 92% for one minute or more Respiratory rate <10 breaths/min counted for 60 seconds Systolic blood pressure < 90 mm Hg.
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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 | Patient Controlled Analgesia | PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment | Systolic blood pressure < 90 mm Hg. |
The full benefit of PCA may accrue over a longer period of time than observed during two-hours. Two-hours not be long enough to capture the full benefit of access to re-dosing in response to the diminishing effect of initial analgesic dose over time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Polly Bijur | Albert Einstein College of Medicine | 718-430-4217 | polly.bijur@einsteinmed.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D004630 | Emergencies |
| D000377 | Agnosia |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| NIH |
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| Usual Care | Other | Usual opioid analgesia determined by the provider |
|
| Patient Satisfaction With Pain Management |
Self report of satisfaction with treatment at120 minutes after baseline |
| 2 hours |
Single question about physician preference for PCA or conventional administration of IV opioids
| 2 hours |
| The Bronx |
| New York |
| 10467 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Location of pain | Count of Participants | Participants |
|
| Initial Numerical Rating Scale (NRS) of pain intensity score | A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. The scale ranged from 0-10 where 0 is no pain and 10 is the worst pain imaginable. Higher numbers on the scale indicate higher pain | Count of Participants | Participants |
|
| Received non-opioid analgesics before arrival to Emergency Department | Count of Participants | Participants |
|
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
|
|
| Secondary | Number of Participants With One or More Adverse Events | Number of participants with one or more adverse events defined by: oxygen saturation measured by pulse oximetry < 92% for one minute or more, respiratory rate <10 breaths/min counted for 60 seconds, or systolic blood pressure < 90 mm Hg. | All patients | Posted | Count of Participants | Participants | 2 hours |
|
|
|
|
| Secondary | Patient Satisfaction With Pain Management | Self report of satisfaction with treatment at120 minutes after baseline | Patients with data at 120 minutes | Posted | Count of Participants | Participants | 2 hours |
|
|
|
|
| Other Pre-specified | Nurse Preference for PCA or Conventional Administration of IV Opioids | Single question about preference for PCA versus preference for conventional administration of IV opioids. | All Registered Nurses | Posted | Count of Participants | Participants | 2 hours |
|
|
|
|
| Other Pre-specified | Physician Preference for PCA or Usual Care | Single question about physician preference for PCA or conventional administration of IV opioids | All Physicians who entered one or more patients in each arm of the study | Posted | Count of Participants | Participants | 2 hours |
|
|
|
|
| 0 |
| 306 |
| 0 |
| 306 |
| 7 |
| 306 |
| EG001 | Usual Care | Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider | 0 | 331 | 0 | 330 | 1 | 330 |
|
| Oxygen desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Oxygen saturation <92% |
|
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| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Measurements |
|---|
|