Trial Outcomes & Findings for Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease (NCT NCT03933397)
NCT ID: NCT03933397
Last Updated: 2023-07-03
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
328 participants
Primary outcome timeframe
baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first
Results posted on
2023-07-03
Participant Flow
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.
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.
Participant milestones
| Measure |
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%.
|
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%.
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
166
|
|
Overall Study
COMPLETED
|
50
|
46
|
|
Overall Study
NOT COMPLETED
|
112
|
120
|
Reasons for withdrawal
| Measure |
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%.
|
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%.
|
|---|---|---|
|
Overall Study
No emergency department visit
|
65
|
71
|
|
Overall Study
Missed emergency department visit
|
25
|
30
|
|
Overall Study
Emergency Department visit for non vaso-occlusive episode diagnosis
|
18
|
15
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
missing pain score
|
1
|
1
|
|
Overall Study
Confirmed COVID-19
|
1
|
2
|
Baseline Characteristics
Data not collected on 1 participant
Baseline characteristics by cohort
| Measure |
Patient-Specific Protocol
n=54 Participants
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%.
|
Weight-based Protocol
n=50 Participants
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%.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=104 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=54 Participants
|
50 Participants
n=50 Participants
|
104 Participants
n=104 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=104 Participants
|
|
Age, Continuous
|
31.3 Years
STANDARD_DEVIATION 8.63 • n=54 Participants
|
29.3 Years
STANDARD_DEVIATION 8.28 • n=50 Participants
|
30.3 Years
STANDARD_DEVIATION 8.48 • n=104 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=54 Participants • Data not collected on 1 participant
|
28 Participants
n=49 Participants • Data not collected on 1 participant
|
64 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Sex: Female, Male
Male
|
18 Participants
n=54 Participants • Data not collected on 1 participant
|
21 Participants
n=49 Participants • Data not collected on 1 participant
|
39 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=54 Participants • Data not collected on 1 participant
|
0 Participants
n=49 Participants • Data not collected on 1 participant
|
2 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=54 Participants • Data not collected on 1 participant
|
49 Participants
n=49 Participants • Data not collected on 1 participant
|
101 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants • Data not collected on 1 participant
|
0 Participants
n=49 Participants • Data not collected on 1 participant
|
0 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants • Data not collected on 1 participant
|
0 Participants
n=49 Participants • Data not collected on 1 participant
|
0 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants • Data not collected on 1 participant
|
0 Participants
n=49 Participants • Data not collected on 1 participant
|
0 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants • Data not collected on 1 participant
|
0 Participants
n=49 Participants • Data not collected on 1 participant
|
0 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=54 Participants • Data not collected on 1 participant
|
48 Participants
n=49 Participants • Data not collected on 1 participant
|
101 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants • Data not collected on 1 participant
|
0 Participants
n=49 Participants • Data not collected on 1 participant
|
0 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants • Data not collected on 1 participant
|
0 Participants
n=49 Participants • Data not collected on 1 participant
|
0 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants • Data not collected on 1 participant
|
1 Participants
n=49 Participants • Data not collected on 1 participant
|
2 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Region of Enrollment
United States
|
54 Participants
n=54 Participants
|
50 Participants
n=50 Participants
|
104 Participants
n=104 Participants
|
|
Clinical Genotypes
SS, SB
|
42 Participants
n=54 Participants
|
35 Participants
n=50 Participants
|
77 Participants
n=104 Participants
|
|
Clinical Genotypes
SC SB+
|
12 Participants
n=54 Participants
|
15 Participants
n=50 Participants
|
27 Participants
n=104 Participants
|
|
Weight
|
73.8 kg
STANDARD_DEVIATION 16.63 • n=54 Participants
|
74.2 kg
STANDARD_DEVIATION 16.49 • n=50 Participants
|
74.0 kg
STANDARD_DEVIATION 16.49 • n=104 Participants
|
|
Leg Ulcers
|
3 Participants
n=53 Participants • Data not collected on 1 participant
|
2 Participants
n=50 Participants • Data not collected on 1 participant
|
5 Participants
n=103 Participants • Data not collected on 1 participant
|
|
Pulmonary Hypertension
|
10 Participants
n=51 Participants • Data not collected on 3 participants
|
6 Participants
n=50 Participants • Data not collected on 3 participants
|
16 Participants
n=101 Participants • Data not collected on 3 participants
|
|
Acute Chest Syndrome
|
39 Participants
n=53 Participants • Data not collected on 3 participants
|
35 Participants
n=48 Participants • Data not collected on 3 participants
|
74 Participants
n=101 Participants • Data not collected on 3 participants
|
|
Retinopathy
|
2 Participants
n=53 Participants • Data not collected on 2 participants
|
4 Participants
n=49 Participants • Data not collected on 2 participants
|
6 Participants
n=102 Participants • Data not collected on 2 participants
|
|
Stroke
|
11 Participants
n=50 Participants • Data not collected on 4 participants
|
8 Participants
n=50 Participants • Data not collected on 4 participants
|
19 Participants
n=100 Participants • Data not collected on 4 participants
|
|
Transient ischemic attack
|
3 Participants
n=49 Participants • Data not collected on 6 participants
|
1 Participants
n=49 Participants • Data not collected on 6 participants
|
4 Participants
n=98 Participants • Data not collected on 6 participants
|
|
Avascular necrosis
|
22 Participants
n=53 Participants • Data not collected on 4 participants
|
17 Participants
n=47 Participants • Data not collected on 4 participants
|
39 Participants
n=100 Participants • Data not collected on 4 participants
|
|
Kidney dysfunction
|
2 Participants
n=51 Participants • Data not collected on 3 participants
|
5 Participants
n=50 Participants • Data not collected on 3 participants
|
7 Participants
n=101 Participants • Data not collected on 3 participants
|
|
Heart Failure
|
3 Participants
n=52 Participants • Data not collected on 2 participants
|
1 Participants
n=50 Participants • Data not collected on 2 participants
|
4 Participants
n=102 Participants • Data not collected on 2 participants
|
|
Gallbladder disease
|
18 Participants
n=52 Participants • Data not collected on 2 participants
|
15 Participants
n=50 Participants • Data not collected on 2 participants
|
33 Participants
n=102 Participants • Data not collected on 2 participants
|
|
Seizure
|
8 Participants
n=50 Participants • Data not collected on 4 participants
|
4 Participants
n=50 Participants • Data not collected on 4 participants
|
12 Participants
n=100 Participants • Data not collected on 4 participants
|
|
Liver Dysfunction
|
3 Participants
n=52 Participants • Data not collected on 2 participants
|
0 Participants
n=50 Participants • Data not collected on 2 participants
|
3 Participants
n=102 Participants • Data not collected on 2 participants
|
PRIMARY outcome
Timeframe: baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came firstPopulation: 3 participants were excluded following COVID-19 diagnosis, 5 participants had missing data following baseline so analysis could not be made.
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.
Outcome measures
| Measure |
Patient-Specific Protocol
n=50 Participants
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.
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%.
|
Weight-based Protocol
n=46 Participants
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%.
|
|---|---|---|
|
The Change in Pain Score
|
-27.0 score on a scale
Standard Deviation 27.54
|
-27.6 score on a scale
Standard Deviation 28.13
|
SECONDARY outcome
Timeframe: From bed placement to discharge or 6 hours whichever comes firstPopulation: 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.
Length of index ED stay in hours from bed placement to discharge
Outcome measures
| Measure |
Patient-Specific Protocol
n=50 Participants
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.
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%.
|
Weight-based Protocol
n=46 Participants
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%.
|
|---|---|---|
|
Length of Index ED (Emergency Department) Stay
|
3.4 hours
Standard Deviation 1.48
|
4.2 hours
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: up to 6 hoursPopulation: Data not collected on 10 participants
Length of care from bed placement to last drug dose in hours.
Outcome measures
| Measure |
Patient-Specific Protocol
n=49 Participants
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.
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%.
|
Weight-based Protocol
n=45 Participants
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%.
|
|---|---|---|
|
Length of Care
|
2.5 hours
Standard Deviation 1.46
|
2.6 hours
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: Up to 7 days post enrollmentNumber of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment
Outcome measures
| Measure |
Patient-Specific Protocol
n=50 Participants
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.
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%.
|
Weight-based Protocol
n=46 Participants
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%.
|
|---|---|---|
|
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment
|
11 hospitalizations
|
14 hospitalizations
|
SECONDARY outcome
Timeframe: Bed placement to discharge or 6 hours, whichever comes firstSide effects and safety at any time during the emergency department visit
Outcome measures
| Measure |
Patient-Specific Protocol
n=50 Participants
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.
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%.
|
Weight-based Protocol
n=46 Participants
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%.
|
|---|---|---|
|
Number of Participants Experiencing Side Effects
Low blood pressure (SBP,90mmHg and/or DBP<50mmHg
|
3 Participants
|
1 Participants
|
|
Number of Participants Experiencing Side Effects
Nausea
|
19 Participants
|
19 Participants
|
|
Number of Participants Experiencing Side Effects
vomiting
|
7 Participants
|
6 Participants
|
|
Number of Participants Experiencing Side Effects
pruritus
|
31 Participants
|
36 Participants
|
|
Number of Participants Experiencing Side Effects
SPO2<95% requiring supplemental oxygen via nasal cannula due to opioid therapy
|
4 Participants
|
7 Participants
|
|
Number of Participants Experiencing Side Effects
Moderate to severe sedation (sedation score of >=3
|
4 Participants
|
5 Participants
|
|
Number of Participants Experiencing Side Effects
Drowsiness
|
15 Participants
|
9 Participants
|
|
Number of Participants Experiencing Side Effects
respiratory depression not requiring intubation
|
0 Participants
|
1 Participants
|
Adverse Events
Patient-Specific Protocol
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Weight-based Protocol
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patient-Specific Protocol
n=50 participants at risk
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.
|
Weight-based Protocol
n=46 participants at risk
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.
|
|---|---|---|
|
General disorders
nausea
|
38.0%
19/50 • Number of events 19 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
41.3%
19/46 • Number of events 19 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
|
General disorders
vomiting
|
14.0%
7/50 • Number of events 7 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
13.0%
6/46 • Number of events 6 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
62.0%
31/50 • Number of events 31 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
78.3%
36/46 • Number of events 36 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
SPO2<95%
|
8.0%
4/50 • Number of events 4 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
15.2%
7/46 • Number of events 7 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
|
General disorders
Moderate to severe sedation
|
8.0%
4/50 • Number of events 4 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
10.9%
5/46 • Number of events 5 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
|
General disorders
Drowsiness
|
30.0%
15/50 • Number of events 15 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
19.6%
9/46 • Number of events 9 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression not requiring intubation
|
0.00%
0/50 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
2.2%
1/46 • Number of events 1 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
|
General disorders
low blood pressure
|
6.0%
3/50 • Number of events 3 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
2.2%
1/46 • Number of events 1 • From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
|
Additional Information
Huiman Barnhardt, PhD
Duke Clinical Research Institute - Duke University Medical Center
Phone: 919-668-7313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place