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The study never screened or enrolled any subjects due to stalled recruitment efforts.
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The purpose of this study is to identify the optimal dosing strategy for low-dose ketamine infusions in adult acute burn injury patients when used with usual pain medications.
This Aim will identify the safest and most optimal dosing strategy for low-dose ketamine infusions. While the hourly rate for low-dose ketamine infusions used for adjunctive analgesia appears to be well-established both in the medical literature and our institutional protocols, there is no information available for this specific population of patients (adult acute burn injury) to know whether the infusions should be utilized for discrete periods of time or should be given continuously. Findings from this study will help provide preliminary data on the optimal dosing strategy of this medication for adjunctive analgesia in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Daily | Active Comparator | Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days. |
|
| Group 2: Continuous | Active Comparator | Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | To be given as intravenous infusion. Ketamine infusions will be started at 5 mg/hr and can be increased by nursing staff based on patient-reported pain relief up to a maximum hourly rate of 20 mg/hr. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain severity | Pain severity measured using the 11-point Visual Numerical Scale (VNS). Scores range from 0 to 10. A score of 0 represents no pain. A score of 10 represents the worst pain imaginable. The score will be collected each day. An average of the score will be calculated for all days of the study. | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Analgesic Consumption | All subjects will be on some form of opioid analgesic. All opioid usage will be recorded. For each 24 hour period, the total daily opioid consumption will be calculated and converted to oral morphine equivalents. The outcome will be reported as an average over all days of participation. | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Nicol, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Opioids | Drug | Standard of care for pain management. |
|
| Side effects / Adverse effects |
Any side effects or adverse effects attributed to ketamine infusions will be recorded. |
| Days 1-4 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |