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| Name | Class |
|---|---|
| Beijing Xiaotangshan Hospital | OTHER |
| The First Hospital of Fangshan District,Beijing | OTHER |
| Beijing Ditan Hospital | OTHER |
| Hengshui People's Hospital |
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To assess the 1-month effects and safety of esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute zoster-related trigeminal neuralgia(ZRTN).
The investigators aim to investigate whether or not esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute ZRTN , and seek a safe, and effective treatment for refractory patients with ZRTN
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine group | Experimental | Besides PRF plus standardized treatment, patients will also receive intravenous infusion of Esketamine ; |
|
| control group | Active Comparator | Patients will only receive PRF plus standardized treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine group | Drug | Patients in the esketamine group will receive intravenous infusion of esketamine besides PRF+standardized treatment.The formula will be intravenous infusion of 0.5mg/kg of esketamine diluted in 50 mL normal saline, starting with intravenous injection of 10 mg of esketamine for 1 minute, and maintaining a dose 8 mg/h.The infusion rate will be adjusted the parameter according to the tolerance of the patients |
| Measure | Description | Time Frame |
|---|---|---|
| the NRS score at 1 month after treatment. | The Numeric Rating Scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain | 1-month period |
| Measure | Description | Time Frame |
|---|---|---|
| the 12-item Short-Form Health Survey (SF-12) score | Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status) | at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| the Pittsburgh Sleep Quality Index (PSQI) score |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo, M.D. | Contact | +86 13611326978 | 13611326978@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Luo, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | 100050 | China |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D006561 | Herpes Simplex |
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D056690 | Prolactin-Releasing Hormone |
| ID | Term |
|---|---|
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| OTHER |
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|
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| PRF group | Drug | Patients in the control group will receive PRF+standardized treatment |
|
|
Sleep quality measured by PSQI score(range 0-21, with higher scores indicating poorer sleep quality) |
| at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| the Patient Global Impression of Change scale (PGIC) | The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC | at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| Analgesics consumption | the type of analgesics and analgesics consumption | at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| Safety assessments | intraoperative complications, PRF-related complications, Eskatamine-related complications | at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |