Acute Pain, Fractures, Multiple Trauma
Conditions
Keywords
pain, trauma
Brief summary
This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.
Interventions
DRUGKetamine
Ketamine administered as patient-controlled analgesia.
DRUGHydromorphone
Hydromorphone administered as patient-controlled analgesia.
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Total Injury Severity Score greater than 9 * Functioning intravenous catheter present per standard of care * Patient planned to receive PCA for acute pain per standard of care * Patient ability to effectively use a PCA device as assessed by the primary attending trauma service * Negative pregnancy test for women of childbearing age
Exclusion criteria
* Body mass index greater than 35 * History of active psychiatric disease * Acute or chronic liver or renal failure * History of heart failure or coronary artery disease * Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy * Patients who abuse alcohol and are at high risk for alcohol withdrawal * Intubated patients * Glasgow Coma Scale score less than 13, or motor subscore less than 6 * Documented allergy to ketamine, hydromorphone, or lorazepam * Pregnancy * Incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Daily Opioid Requirement | Participants will be followed for their entire hospital stay, an expected average of 1 week. | Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breakthrough Daily Opioid Requirement | Participants will be followed for their entire hospital stay, an expected average of 1 week | Breakthrough daily opioid requirement in milligrams of morphine equivalents/day |
| Median Pain Score | Participants will be followed for their entire hospital stay, an expected average of 1 week | Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Ketamine 90mg/30 mL PCA (3 mg/mL)
Ketamine: Ketamine administered as patient-controlled analgesia. | 10 |
| Hydromorphone Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Hydromorphone: Hydromorphone administered as patient-controlled analgesia. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Total | Ketamine | Hydromorphone |
|---|---|---|---|
| Age, Continuous | 30 years | 39 years | 26 years |
| Blunt Trauma | 19 Participants | 10 Participants | 9 Participants |
| BMI | 27 kg/m^2 | 27 kg/m^2 | 26.5 kg/m^2 |
| Injury Severity Score | 29 scores on a scale | 29 scores on a scale | 28 scores on a scale |
| Penetrating Trauma | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 16 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 10 | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Total Daily Opioid Requirement
Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents
Time frame: Participants will be followed for their entire hospital stay, an expected average of 1 week.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine | Total Daily Opioid Requirement | 10 mg morphine equivalents/day |
| Hydromorphone | Total Daily Opioid Requirement | 42.5 mg morphine equivalents/day |
Secondary
Breakthrough Daily Opioid Requirement
Breakthrough daily opioid requirement in milligrams of morphine equivalents/day
Time frame: Participants will be followed for their entire hospital stay, an expected average of 1 week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine | Breakthrough Daily Opioid Requirement | 10 mg morphine equivalents/day |
| Hydromorphone | Breakthrough Daily Opioid Requirement | 10 mg morphine equivalents/day |
Secondary
Median Pain Score
Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.
Time frame: Participants will be followed for their entire hospital stay, an expected average of 1 week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine | Median Pain Score | 6.3 scores on a scale |
| Hydromorphone | Median Pain Score | 5.3 scores on a scale |