Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U24HL137907-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Due to COVID enrollment numbers needed to meet the primary endpoint will not be met.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Specific Protocol | Experimental | Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home, what was needed during their past hospital and emergency department visits to treat pain and doses that have been effective and safe in the past. |
|
| Weight-based Protocol | Experimental | Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Specific Protocol | Other | Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home for pain and what was needed during their past hospital and emergency department visits to treat pain. Medicines will include opioids, either morphine or hydromorphone. A member of the outpatient SCD provider team will review the patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective and safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Pain Score | Pain is measured by having the patient mark pain on a scale of 0 to 100, with 0 being no pain and 100 being the worst pain ever. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a vision and verbal score if possible collecting the visual score first. For the analysis, the visual score was used if available for the primary outcome. if not available, the verbal score was used. | baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Index ED (Emergency Department) Stay | Length of index ED stay in hours from bed placement to discharge | From bed placement to discharge or 6 hours whichever comes first |
| Length of Care |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huiman Barnhart, PhD | Duke University | Principal Investigator |
| Paula Tanabe, PhD | Duke University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States | ||
| Henry Ford Health System |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were consented & randomized in ED, clinic or by phone with the onset of COVID-19. Pain protocols were written based on the randomization arm assigned and uploaded to the Electronic Medical Record for use if the participant presented to the emergency department (ED) for pain related to their sickle cell disease. Patients were evaluated for COVID-19 at the ED visit & excluded if COVID positive. During the ED visit, baseline date were collected following bed placement of participant.
Patients were enrolled between August 13, 2019 - May 13 2022 at 6 academic institutions. Institutions selected based on minimum average of two ED (Emergency Department) visits/day by patients with SCD(Sickle Cell Disease) for treatment of VOE (Vaso-occlusive pain events), hematologist willing to randomize patients to the treatment arms, informatics support to post the protocols in electronic health record and infrastructure to support both enrollment of subjects and prospective data collection.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patient-Specific Protocol | Patients assigned to this arm will be given pain medicine(s) based on pain medicine(s) they take at home, what was needed during past hospital and emergency department visits to treat pain and doses that have been effective & safe in the past. Patient-Specific Protocol: Patients assigned to this arm will be given pain medicine(s) based on pain medicine(s) they take at home and what was needed during their past hospital and emergency department visits to treat pain. Medicines include opioids, either morphine or hydromorphone. An outpatient SCD provider team will review patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective & safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2019 | Apr 11, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Weight-based Protocol | Other | Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. |
|
| Morphine | Drug | 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
|
|
| Hydromorphone | Drug | 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
|
|
Length of care from bed placement to last drug dose in hours.
| up to 6 hours |
| Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment | Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment | Up to 7 days post enrollment |
| Number of Participants Experiencing Side Effects | Side effects and safety at any time during the emergency department visit | Bed placement to discharge or 6 hours, whichever comes first |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Wayne State University | Detroit | Michigan | 48202 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Case Western University | Cleveland | Ohio | 44106 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| FG001 | Weight-based Protocol | Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Weight-based Protocol: Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants arrived at the emergency department and once determined that they were not COVID + and were there for a vaso-occlusive episode and bed placement occurred, baseline data were collected. Baseline data were not collected on 8 participants following bed placement. 1 withdrew consent, 2 were investigator decision, 3 confirmed COVID + and 1 did not provide baseline information.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patient-Specific Protocol | Patients assigned to this arm will be given pain medicine(s) based on pain medicine(s) they take at home and what was needed during their past hospital and emergency department visits to treat pain. Medicines include opioids, either morphine or hydromorphone. An outpatient SCD provider team will review patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective & safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
| BG001 | Weight-based Protocol | Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Weight-based Protocol: Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Data not collected on 1 participant | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Data not collected on 1 participant | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Data not collected on 1 participant | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Clinical Genotypes | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Leg Ulcers | Data not collected on 1 participant | Count of Participants | Participants |
| |||||||||||||||
| Pulmonary Hypertension | Data not collected on 3 participants | Count of Participants | Participants |
| |||||||||||||||
| Acute Chest Syndrome | Data not collected on 3 participants | Count of Participants | Participants |
| |||||||||||||||
| Retinopathy | Data not collected on 2 participants | Count of Participants | Participants |
| |||||||||||||||
| Stroke | Data not collected on 4 participants | Count of Participants | Participants |
| |||||||||||||||
| Transient ischemic attack | Data not collected on 6 participants | Count of Participants | Participants |
| |||||||||||||||
| Avascular necrosis | Data not collected on 4 participants | Count of Participants | Participants |
| |||||||||||||||
| Kidney dysfunction | Data not collected on 3 participants | Count of Participants | Participants |
| |||||||||||||||
| Heart Failure | Data not collected on 2 participants | Count of Participants | Participants |
| |||||||||||||||
| Gallbladder disease | Data not collected on 2 participants | Count of Participants | Participants |
| |||||||||||||||
| Seizure | Data not collected on 4 participants | Count of Participants | Participants |
| |||||||||||||||
| Liver Dysfunction | Data not collected on 2 participants | Count of Participants | 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 | The Change in Pain Score | Pain is measured by having the patient mark pain on a scale of 0 to 100, with 0 being no pain and 100 being the worst pain ever. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a vision and verbal score if possible collecting the visual score first. For the analysis, the visual score was used if available for the primary outcome. if not available, the verbal score was used. | 3 participants were excluded following COVID-19 diagnosis, 5 participants had missing data following baseline so analysis could not be made. | Posted | Mean | Standard Deviation | score on a scale | baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Index ED (Emergency Department) Stay | Length of index ED stay in hours from bed placement to discharge | Patients had to be placed in bed in emergency department. Time was calculated from placement to change in disposition or at the end of 6 hours whichever came first. | Posted | Mean | Standard Deviation | hours | From bed placement to discharge or 6 hours whichever comes first |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Care | Length of care from bed placement to last drug dose in hours. | Data not collected on 10 participants | Posted | Mean | Standard Deviation | hours | up to 6 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment | Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment | Posted | Number | hospitalizations | Up to 7 days post enrollment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Side Effects | Side effects and safety at any time during the emergency department visit | Posted | Count of Participants | Participants | Bed placement to discharge or 6 hours, whichever comes first |
|
From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient-Specific Protocol | Patients assigned to this treatment protocol will be given pain medicine(s) based on pain medicine(s) taken at home & what was needed during past emergency department visits to treat pain. Medicines include opioids, morphine or hydromorphone. A member of the outpatient provider team reviews patient's medical record to determine patient's maximum home opioid dose, previous ED analgesic medication(s) & doses that have been effective & safe in the past. Patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing > or equal to 90 kgs. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing > or equal to 90 kgs. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. There are only two, not four, randomized interventions in this trial: patient specific pain management protocol and weight-based pain management protocol. Here the word "protocol" refers to pain management approach. The AEs have been submitted by each of these two interventions. | 0 | 50 | 0 | 50 | 50 | 50 |
| EG001 | Weight-based Protocol | Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Weight-based Protocol: Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. There are only two, not four, randomized interventions in this trial: patient specific pain management protocol and weight-based pain management protocol. Here the word "protocol" refers to pain management approach. The AEs have been submitted by each of these two interventions. | 0 | 46 | 0 | 46 | 46 | 46 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | General disorders | Systematic Assessment |
| ||
| vomiting | General disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| SPO2<95% | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Moderate to severe sedation | General disorders | Systematic Assessment |
| ||
| Drowsiness | General disorders | Systematic Assessment |
| ||
| Respiratory depression not requiring intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| low blood pressure | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Huiman Barnhardt, PhD | Duke Clinical Research Institute - Duke University Medical Center | 919-668-7313 | huiman.barnhart@duke.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2019 | Jun 7, 2023 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2020 | May 24, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Weight-based Protocol | Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Weight-based Protocol: Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
|
|
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Weight-based Protocol: Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
|
|
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Weight-based Protocol: Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
|
|
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Weight-based Protocol: Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. Morphine: 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. Hydromorphone: 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. |
|
|