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To evaluate the efficacy of three regimens of sub anesthetic dose of ketamine infusion in relieving chronic refractory pain in patients with complex regional pain syndrome
Ketamine N-methyl-D-aspartate (NMDA) receptor blocker that has recently been studied for its analgesic effect is a phencyclidine or phenyl cyclohexyl piperidine (PCP) derivative that initially became commercially available for human use in 1970 as a rapid-acting intravenous (IV) anesthetic. It is currently classified by the Food and Drug Administration (FDA) as an anesthetic induction agent in doses ranging from 1 to 4.5 mg/kg.
Ketamine has proven to be a desirable drug, despite of its induction dissociative effects and abuse potential. It is favorable due to its short half-life and lack of clinically significant respiratory depression. In addition to its anesthetic effects, ketamine has analgesic, anti-inflammatory, and antidepressant activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h) at post anesthetic care unit(PACU) over 6 hours for 3days |
|
| Group B | Experimental | patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 5 days . |
|
| Group C | Experimental | patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h) at post anesthetic care unit(PACU) over 6 hours for 3days . |
|
| Measure | Description | Time Frame |
|---|---|---|
| degree of chronic pain reduction | using Brief Pain Inventory short form (BPI-SF) questionnaire. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. | up to 3 months post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the degree of chronic pain score | Numerical rating scales (NRS) is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being "no pain" and 10 being "the worst pain imaginable" | up to 3 months post infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El-garbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
after the end of study for one year
The data will be available upon a reasonable request from the corresponding author
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine | Drug | patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 5 days |
|
| Ketamine | Drug | patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 7 days |
|
| Side effects |
Headache, Nausea and vomiting |
| up to 3 months post infusion |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |