Trial Outcomes & Findings for Dronabinol On the Pain Experience (NCT NCT05820685)
NCT ID: NCT05820685
Last Updated: 2025-06-11
Results Overview
This will be calculated by calculated by taking the total of MMEs from all opioids received and dividing by length of stay
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
484 participants
Primary outcome timeframe
From time of admission to time of discharge (about 11 days after admission)
Results posted on
2025-06-11
Participant Flow
Participant milestones
| Measure |
Standard of Care
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Overall Study
STARTED
|
241
|
243
|
|
Overall Study
COMPLETED
|
235
|
234
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
102 participant in the Standard of Care arm had rib fractures. 100 participant in the Standard of Care + Dronabinol arm had rib fractures. This baseline measure is for participants with rib fractures.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=235 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Total
n=469 Participants
Total of all reporting groups
|
|---|---|---|---|
|
number of rib fractures (only participants with rib fractures)
|
5 rib fractures
n=102 Participants • 102 participant in the Standard of Care arm had rib fractures. 100 participant in the Standard of Care + Dronabinol arm had rib fractures. This baseline measure is for participants with rib fractures.
|
4 rib fractures
n=100 Participants • 102 participant in the Standard of Care arm had rib fractures. 100 participant in the Standard of Care + Dronabinol arm had rib fractures. This baseline measure is for participants with rib fractures.
|
5 rib fractures
n=202 Participants • 102 participant in the Standard of Care arm had rib fractures. 100 participant in the Standard of Care + Dronabinol arm had rib fractures. This baseline measure is for participants with rib fractures.
|
|
Age, Continuous
|
38 years
n=235 Participants
|
38 years
n=234 Participants
|
38 years
n=469 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=235 Participants
|
67 Participants
n=234 Participants
|
127 Participants
n=469 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=235 Participants
|
167 Participants
n=234 Participants
|
342 Participants
n=469 Participants
|
|
Race/Ethnicity, Customized
White
|
66 Participants
n=235 Participants
|
77 Participants
n=234 Participants
|
143 Participants
n=469 Participants
|
|
Race/Ethnicity, Customized
Black
|
66 Participants
n=235 Participants
|
64 Participants
n=234 Participants
|
130 Participants
n=469 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
83 Participants
n=235 Participants
|
83 Participants
n=234 Participants
|
166 Participants
n=469 Participants
|
|
Race/Ethnicity, Customized
Other
|
20 Participants
n=235 Participants
|
10 Participants
n=234 Participants
|
30 Participants
n=469 Participants
|
|
Region of Enrollment
United States
|
235 participants
n=235 Participants
|
234 participants
n=234 Participants
|
469 participants
n=469 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Head
|
0 score on a scale
n=235 Participants
|
0 score on a scale
n=234 Participants
|
0 score on a scale
n=469 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Chest
|
1 score on a scale
n=235 Participants
|
2 score on a scale
n=234 Participants
|
1 score on a scale
n=469 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Abdomen
|
0 score on a scale
n=235 Participants
|
0 score on a scale
n=234 Participants
|
0 score on a scale
n=469 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Extremity
|
2 score on a scale
n=235 Participants
|
2 score on a scale
n=234 Participants
|
2 score on a scale
n=469 Participants
|
|
Injury Severity Score (ISS)
|
17 score on a scale
n=235 Participants
|
14 score on a scale
n=234 Participants
|
14 score on a scale
n=469 Participants
|
|
Number of Participants with a blunt injury
|
181 Participants
n=235 Participants
|
175 Participants
n=234 Participants
|
356 Participants
n=469 Participants
|
|
Number of Participants with Rib Fractures
|
102 Participants
n=235 Participants
|
100 Participants
n=234 Participants
|
202 Participants
n=469 Participants
|
|
Number of participants with flail segment
|
19 Participants
n=235 Participants
|
6 Participants
n=234 Participants
|
25 Participants
n=469 Participants
|
|
Number of participants with long bone fracture
|
79 Participants
n=235 Participants
|
72 Participants
n=234 Participants
|
151 Participants
n=469 Participants
|
|
Number of participants with vertebral body fracture
|
39 Participants
n=235 Participants
|
43 Participants
n=234 Participants
|
82 Participants
n=469 Participants
|
|
Number of participants with pelvis or acetabulum fracture
|
49 Participants
n=235 Participants
|
37 Participants
n=234 Participants
|
86 Participants
n=469 Participants
|
|
Number of participants with traumatic brain injury
|
25 Participants
n=235 Participants
|
32 Participants
n=234 Participants
|
57 Participants
n=469 Participants
|
|
Number of participants who underwent laparotomy procedure
|
24 Participants
n=235 Participants
|
30 Participants
n=234 Participants
|
54 Participants
n=469 Participants
|
|
Number of participants who underwent thoracotomy procedure
|
0 Participants
n=235 Participants
|
0 Participants
n=234 Participants
|
0 Participants
n=469 Participants
|
|
Number of participants who underwent amputation procedure
|
7 Participants
n=235 Participants
|
3 Participants
n=234 Participants
|
10 Participants
n=469 Participants
|
|
Number of participants who underwent any procedure
|
181 Participants
n=235 Participants
|
184 Participants
n=234 Participants
|
365 Participants
n=469 Participants
|
|
Number of Participants With Prior Opioid Use
No
|
145 Participants
n=235 Participants
|
151 Participants
n=234 Participants
|
296 Participants
n=469 Participants
|
|
Number of Participants With Prior Opioid Use
Yes
|
84 Participants
n=235 Participants
|
68 Participants
n=234 Participants
|
152 Participants
n=469 Participants
|
|
Number of Participants With Prior Opioid Use
Unknown
|
6 Participants
n=235 Participants
|
15 Participants
n=234 Participants
|
21 Participants
n=469 Participants
|
|
Number of Participants with a History of Smoking
No
|
149 Participants
n=235 Participants
|
146 Participants
n=234 Participants
|
295 Participants
n=469 Participants
|
|
Number of Participants with a History of Smoking
Yes
|
76 Participants
n=235 Participants
|
76 Participants
n=234 Participants
|
152 Participants
n=469 Participants
|
|
Number of Participants with a History of Smoking
Unknown
|
10 Participants
n=235 Participants
|
12 Participants
n=234 Participants
|
22 Participants
n=469 Participants
|
|
Number of Participants with a Positive Alcohol Screen
No
|
91 Participants
n=235 Participants
|
85 Participants
n=234 Participants
|
176 Participants
n=469 Participants
|
|
Number of Participants with a Positive Alcohol Screen
Yes
|
37 Participants
n=235 Participants
|
35 Participants
n=234 Participants
|
72 Participants
n=469 Participants
|
|
Number of Participants with a Positive Alcohol Screen
Not Performed
|
107 Participants
n=235 Participants
|
114 Participants
n=234 Participants
|
221 Participants
n=469 Participants
|
|
Number of Participants with a Positive Drug Screen
No
|
145 Participants
n=235 Participants
|
140 Participants
n=234 Participants
|
285 Participants
n=469 Participants
|
|
Number of Participants with a Positive Drug Screen
Yes
|
44 Participants
n=235 Participants
|
39 Participants
n=234 Participants
|
83 Participants
n=469 Participants
|
|
Number of Participants with a Positive Drug Screen
Not Performed
|
46 Participants
n=235 Participants
|
55 Participants
n=234 Participants
|
101 Participants
n=469 Participants
|
|
Number of rib fractures (all participants)
|
0 rib fractures
n=235 Participants
|
0 rib fractures
n=234 Participants
|
0 rib fractures
n=469 Participants
|
|
Unit of admission
Floor
|
164 Participants
n=235 Participants
|
167 Participants
n=234 Participants
|
331 Participants
n=469 Participants
|
|
Unit of admission
Intermediate unit
|
32 Participants
n=235 Participants
|
31 Participants
n=234 Participants
|
63 Participants
n=469 Participants
|
|
Unit of admission
Intensive care unit
|
32 Participants
n=235 Participants
|
33 Participants
n=234 Participants
|
65 Participants
n=469 Participants
|
|
Unit of admission
Other
|
7 Participants
n=235 Participants
|
3 Participants
n=234 Participants
|
10 Participants
n=469 Participants
|
PRIMARY outcome
Timeframe: From time of admission to time of discharge (about 11 days after admission)This will be calculated by calculated by taking the total of MMEs from all opioids received and dividing by length of stay
Outcome measures
| Measure |
Standard of Care
n=235 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Total Morphine Milligram Equivalents (MME) Per Day
|
15 MME Per Day
Interval 9.0 to 25.0
|
17 MME Per Day
Interval 10.0 to 26.0
|
SECONDARY outcome
Timeframe: From time of admission to time of discharge (about 11 days after admission)This will be calculated by calculated by taking the total of MMEs from all opioids received
Outcome measures
| Measure |
Standard of Care
n=235 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Total Morphine Milligram Equivalents (MME) Over Hospital Stay
|
99 Morphine Milligram Equivalents (MME)
Interval 50.0 to 197.0
|
99 Morphine Milligram Equivalents (MME)
Interval 48.0 to 182.0
|
SECONDARY outcome
Timeframe: From time of admission to time of discharge (about 11 days after admission)Population: Data were not collected for this outcome measure because it was not charted by the bedside nurse.
This is a 4 item questionnaire and each is scored from 0(no pain) to 10( as bad as it could be, nothing else matters), enhanced with functional word descriptor anchors at each pain level and "traffic light" color coded bars to delineate levels of pain; mild (1 to 4, green), moderate (5 to 6, yellow), and severe (7 to 10, red) pain a higher number indicating more pain Average pain score during the course of the hospital stay will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Discharge (about 11 days after admission)Outcome measures
| Measure |
Standard of Care
n=235 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication
|
133 Participants
|
144 Participants
|
SECONDARY outcome
Timeframe: Discharge (about 11 days after admission)Outcome measures
| Measure |
Standard of Care
n=235 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication
|
102 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: From time of admission to time of discharge (about 11 days after admission)Outcome measures
| Measure |
Standard of Care
n=235 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Number of Participants That Have Incidences of Opioid-related Complications, Such as Ileus, Aspiration, Unplanned Intubation, Unplanned Admission to an Intensive Care Unit, and Use of an Opioid-reversal Agent.
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From time of admission to time of discharge (about 11 days after admission)Outcome measures
| Measure |
Standard of Care
n=235 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Hospital Length of Stay
|
6 days
Interval 4.0 to 11.0
|
6 days
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: 30 daysThis will be calculated as (30 days-length of stay (LOS))
Outcome measures
| Measure |
Standard of Care
n=235 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Number of Hospital Free Days
|
24 Days
Interval 19.0 to 26.0
|
24 Days
Interval 21.0 to 27.0
|
SECONDARY outcome
Timeframe: From time of admission to ICU to time of discharge from ICU (about 12 days after admission)Population: Only the participants with \> 0 ICU days were analyzed for this outcome measure.
Outcome measures
| Measure |
Standard of Care
n=39 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=42 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
ICU Length of Stay (Participants With >0 ICU Days)
|
5 days
Interval 3.0 to 12.0
|
6 days
Interval 3.0 to 10.0
|
SECONDARY outcome
Timeframe: From time of intubation to time of extubation (about 14 days after admission)Population: Only the participants with \> 0 days on a ventilator were analyzed for this outcome measure.
Outcome measures
| Measure |
Standard of Care
n=23 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=23 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator)
|
3 days
Interval 2.0 to 11.0
|
6 days
Interval 3.0 to 14.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only the participants with \> 0 ICU days were analyzed for this outcome measure.
This will be calculated as (30 days-number of days in ICU)
Outcome measures
| Measure |
Standard of Care
n=39 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=42 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Number of ICU Free Days (Participants With >0 ICU Days)
|
25 days
Interval 18.0 to 27.0
|
25 days
Interval 20.0 to 27.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only the participants with \> 0 days on a ventilator were analyzed for this outcome measure.
This will be calculated as (30 days-number of days spent on ventilator)
Outcome measures
| Measure |
Standard of Care
n=23 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=23 Participants
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
|
Number of Ventilator Free Days (Participants With >0 Days on a Ventilator)
|
27 days
Interval 19.0 to 28.0
|
24 days
Interval 16.0 to 27.0
|
Adverse Events
Standard of Care
Serious events: 10 serious events
Other events: 0 other events
Deaths: 5 deaths
Standard of Care + Dronabinol
Serious events: 13 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Standard of Care
n=235 participants at risk
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
Standard of Care + Dronabinol
n=234 participants at risk
Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
|
|---|---|---|
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General disorders
Unplanned intubation
|
1.3%
3/235 • From hospital admission up to hospital discharge (about 11 days)
|
1.7%
4/234 • From hospital admission up to hospital discharge (about 11 days)
|
|
Gastrointestinal disorders
Unplanned ICU
|
3.4%
8/235 • From hospital admission up to hospital discharge (about 11 days)
|
5.6%
13/234 • From hospital admission up to hospital discharge (about 11 days)
|
Other adverse events
Adverse event data not reported
Additional Information
John Harvin, MD, FACS
The University of Texas Health Science Center at Houston
Phone: 713-500-7244
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place