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| ID | Type | Description | Link |
|---|---|---|---|
| NTI-NTRR15-13 | Other Grant/Funding Number | National Trauma Institute; Departement of Defense |
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Funding withdrawn - slow enrollment
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Congressionally Directed Medical Research Programs | FED |
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The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual Care-Opiate (UC-O), dose/timing as per Burn Center protocol).
Department of Defense (DoD) and the U.S. Army Medical Research and Materiel Command (USAMRMC) are funding this RCT for the following reasons:
Primary Aims:
and
Secondary Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl Plus Ketamine | Experimental | Study drug group
Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication. |
|
| Fentanyl Plus Saline | Active Comparator | Usual care group
FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | Information included in arm descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Wound Care Pain | Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment. | Up to 40 days |
| Trajectory of Mean Wound Care Session Pain Within Sessions | Trajectory of average pain within session | 7-days, within session |
| Trajectory of Mean Wound Care Session Pain Across Sessions | Trajectory of average pain across 7 day study protocol | 7-Days across sessions |
| Opiate Sparing Effect | Pro Re Nata (PRN) pain management or adjunct expressed in opiate equivalents (e.g., anxiolytic) or premed (e.g., non-protocol medications for pain, anxiety, etc); post-session (1 and 6 hours post session , e.g., pain, anxiolytic, etc). | 37 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post Traumatic Stress Disorder (PTSD) Symptoms as Assessed by Davidson Trauma Scale | PTSD symptoms score as assessed by Davidson Trauma Scale consisting of 17 items (symptoms) with each item measured for severity and frequency. Each item is rated 0 - 4. Overall score ranges from 0 to 136, with higher scores indicating higher frequency and severity. | 37 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A Fauerbach, PhD | Johns Hopkins University SOM | Principal Investigator |
| Kevin Gerold, DOJD | Johns Hopkins University SOM | Principal Investigator |
| Julie Caffrey, DO | Johns Hopkins University SOM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Burn Center | Baltimore | Maryland | 21224 | United States |
Plan not operationalized as yet.
Data will become available by 1 year after final data publication and remain available for indefinitely.
Written request from faculty investigator to PI or Study Director specifying planned safety & monitoring plan and data analytic aims and hypotheses
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl Plus Ketamine | Study drug group
Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication. ketamine: Information included in arm descriptions Fentanyl: Information included in arm descriptions |
| FG001 | Fentanyl Plus Saline | Usual care group
FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication. Fentanyl: Information included in arm descriptions |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl Plus Ketamine | Study drug group
Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication. ketamine: Information included in arm descriptions Fentanyl: Information included in arm descriptions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Wound Care Pain | Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment. | Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure | Posted | Up to 40 days |
|
End of study (approximately 37 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fentanyl Plus Ketamine | Study drug group
Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication. ketamine: Information included in arm descriptions Fentanyl: Information included in arm descriptions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at wound site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James A. Fauerbach | Johns Hopkins University | 410-550-0890 | jfauerb1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2017 | Jan 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005283 | Fentanyl |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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Randomized, placebo-controlled, repeated exposure (twice daily, 7 days), safety and efficacy trial of Usual Care (fentanyl PLUS saline / placebo) versus Usual Care plus Study Drug Augmentation (fentanyl PLUS ketamine) in reducing acute pain severity assessed before, during and after wound care for acute burn injury in the Burn Center of an Academic Medical Center.
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Pharmacy receives order from provider and then prepares the study drug in an unmarked, nondescript delivery system ("bag") and the study drug information is entered from the bag into the pump so that delivery that is timed and volume controlled per study protocol. This is hung next to patient, connected and started. Masked personnel include provider (order study drug protocol), nurse (wound care), data assessor (Research Assistant), and consenting participant (patient with acute burn).
| Fentanyl | Drug | Information included in arm descriptions |
|
|
| Depression Symptoms as Assessed by the Patient Health Questionnaire | Severity and trajectory of depression symptoms as assessed by the Patient Health Questionnaire (PHQ) 9. The questionnaire has 9 items with each rated from 0 to 3. Overall scores ranges from 0 to 27 with 1-4 being minimal depression, 5-9 being mild depression, 10-14 being moderate depression, 15-19 being moderately severe depression and 20-27 being severe depression. | 37 days |
| BG001 | Fentanyl Plus Saline | Usual care group
FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication. Fentanyl: Information included in arm descriptions |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Fentanyl Plus Saline | Usual care group
FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication. Fentanyl: Information included in arm descriptions |
|
| Primary | Trajectory of Mean Wound Care Session Pain Within Sessions | Trajectory of average pain within session | Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure | Posted | 7-days, within session |
|
|
| Primary | Trajectory of Mean Wound Care Session Pain Across Sessions | Trajectory of average pain across 7 day study protocol | Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure | Posted | 7-Days across sessions |
|
|
| Primary | Opiate Sparing Effect | Pro Re Nata (PRN) pain management or adjunct expressed in opiate equivalents (e.g., anxiolytic) or premed (e.g., non-protocol medications for pain, anxiety, etc); post-session (1 and 6 hours post session , e.g., pain, anxiolytic, etc). | Data was not collected for this outcome measure. | Posted | 37 days |
|
|
| Secondary | Post Traumatic Stress Disorder (PTSD) Symptoms as Assessed by Davidson Trauma Scale | PTSD symptoms score as assessed by Davidson Trauma Scale consisting of 17 items (symptoms) with each item measured for severity and frequency. Each item is rated 0 - 4. Overall score ranges from 0 to 136, with higher scores indicating higher frequency and severity. | Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure | Posted | 37 days |
|
|
| Secondary | Depression Symptoms as Assessed by the Patient Health Questionnaire | Severity and trajectory of depression symptoms as assessed by the Patient Health Questionnaire (PHQ) 9. The questionnaire has 9 items with each rated from 0 to 3. Overall scores ranges from 0 to 27 with 1-4 being minimal depression, 5-9 being mild depression, 10-14 being moderate depression, 15-19 being moderately severe depression and 20-27 being severe depression. | Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure | Posted | 37 days |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Fentanyl Plus Saline | Usual care group
FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication. Fentanyl: Information included in arm descriptions | 0 | 2 | 0 | 2 | 1 | 2 |
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| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |