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The purpose of this study is to identify the effect dronabinol has on opioid exposure when used as an adjunct to the current standard multi-modal pain regimen (MMPR)
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-06-11
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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.
Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
This will be calculated by calculated by taking the total of MMEs from all opioids received and dividing by length of stay
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 235 | 15 | 9 to 25 |
| Standard of Care + Dronabinol | 234 | 17 | 10 to 26 |
This will be calculated by calculated by taking the total of MMEs from all opioids received
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 235 | 99 | 50 to 197 |
| Standard of Care + Dronabinol | 234 | 99 | 48 to 182 |
Eligibility
primary outcomes
Time frame: 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
secondary outcomes
Time frame: 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
Time frame: From time of admission to time of discharge (about 11 days after admission)
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.
Time frame: Discharge (about 11 days after admission)
Time frame: Discharge (about 11 days after admission)
Time frame: From time of admission to time of discharge (about 11 days after admission)
Time frame: From time of admission to time of discharge (about 11 days after admission)
Time frame: 30 days
This will be calculated as (30 days-length of stay (LOS))
Time frame: From time of admission to ICU to time of discharge from ICU (about 12 days after admission)
Publications
No exact PMID-linked public article is currently readable locally.
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.
Population: Data were not collected for this outcome measure because it was not charted by the bedside nurse.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 235 | 133 | - |
| Standard of Care + Dronabinol | 234 | 144 | - |
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 235 | 102 | - |
| Standard of Care + Dronabinol | 234 | 90 | - |
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 235 | 10 | - |
| Standard of Care + Dronabinol | 234 | 13 | - |
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 235 | 6 | 4 to 11 |
| Standard of Care + Dronabinol | 234 | 6 | 3 to 9 |
This will be calculated as (30 days-length of stay (LOS))
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 235 | 24 | 19 to 26 |
| Standard of Care + Dronabinol | 234 | 24 | 21 to 27 |
Population: Only the participants with \> 0 ICU days were analyzed for this outcome measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 39 | 5 | 3 to 12 |
| Standard of Care + Dronabinol | 42 | 6 | 3 to 10 |
Population: Only the participants with \> 0 days on a ventilator were analyzed for this outcome measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 23 | 3 | 2 to 11 |
| Standard of Care + Dronabinol | 23 | 6 | 3 to 14 |
This will be calculated as (30 days-number of days in ICU)
Population: Only the participants with \> 0 ICU days were analyzed for this outcome measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 39 | 25 | 18 to 27 |
| Standard of Care + Dronabinol | 42 | 25 | 20 to 27 |
This will be calculated as (30 days-number of days spent on ventilator)
Population: Only the participants with \> 0 days on a ventilator were analyzed for this outcome measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Standard of Care | 23 | 27 | 19 to 28 |
| Standard of Care + Dronabinol | 23 | 24 | 16 to 27 |
| Milestone | Standard of Care | Standard of Care + Dronabinol |
|---|---|---|
| STARTED | 241 | 243 |
| COMPLETED | 235 | 234 |
| NOT COMPLETED | 6 | 9 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Unplanned intubation | General disorders | Standard of Care: 3 / 235 · Standard of Care + Dronabinol: 4 / 234 |
| Unplanned ICU | Gastrointestinal disorders | Standard of Care: 8 / 235 · Standard of Care + Dronabinol: 13 / 234 |
Time frame: From time of intubation to time of extubation (about 14 days after admission)
Time frame: 30 days
This will be calculated as (30 days-number of days in ICU)
Time frame: 30 days
This will be calculated as (30 days-number of days spent on ventilator)