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| ID | Type | Description | Link |
|---|---|---|---|
| GM48085 |
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the manufacturing of preservative free ketorolac (Acular-PF) was discontinued
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic painkiller):
Intravenous (IV) remifentanil stimulates spinal COX activity, leading to increased Cerebrospinal fluid CSF) prostaglandin E2 (PGE2) concentrations and areas of capsaicin-induced mechanical hypersensitivity after remifentanil infusion, and these effects will be blocked by intrathecal ketorolac.
Areas of mechanical hyperalgesia and allodynia will be established by topical capsaicin + intermittent heat in healthy volunteers, who will be randomized to receive intrathecal saline or ketorolac during remifentanil infusion, with primary outcome measure area of hyperalgesia and secondary outcome measure Cerebrospinal fluid (CSF) prostaglandin E2 (PGE2) concentration after stopping remifentanil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Ketorolac | Experimental | In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment. |
|
| Placebo intrathecal injection | Placebo Comparator | In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketorolac | Drug | single intrathecal injection of ketorolac 2 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hyperalgesia | Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration | Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac | 2.5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C. Eisenach, M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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31 healthy subjects between the ages of 19-51 were recruited and 30 were randomized between the dates for 11/20/2007 and 8/17/2010. Subjects were seen for all study related visits in the General Clinical Research Center at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrathecal Ketorolac | In the presence of a remifentanil infusion subjects received a single intrathecal injection of ketorolac 2 mg. The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration. The remifentanil infusion was titrated based on the subjects' pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes. |
| FG001 | Placebo Intrathecal Injection | In the presence of remifentanil subjects received a single intrathecal injection of placebo (preservative-free normal saline). The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration. The remifentanil infusion was titrated based on the subjects' pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrathecal Ketorolac | In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg |
| BG001 | Placebo Intrathecal Injection | In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Hyperalgesia | Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament | Posted | Mean | Standard Deviation | centimeters^2 | 24 hours |
|
2 weeks
Subjects were followed up for 2 weeks and questioned for any adverse events
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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 | Intrathecal Ketorolac | In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James C. Eisenach, M.D. | Wake Forest School of Medicine | 336-716-4498 | jimeisenach@gmail.com |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000077208 | Remifentanil |
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| placebo | Drug | subject will receive a placebo (preservative free normal saline) spinal injection |
|
| remifentanil | Drug | All subjects will receive a remifentanil infusion |
|
|
| Capsaicin | Drug | Topical capsaicin pain model utilized for each subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration | Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac | 11 Subjects in the Intrathecal Ketorolac group received post study treatment analysis of CSF for PGE2. We were not able to obtain CSF samples in 3 of the subjects post study drug injection. | Posted | Mean | Standard Deviation | picograms per milliliter | 2.5 hours |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo Intrathecal Injection | In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) | 0 | 16 | 0 | 16 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |