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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
174
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
Patients in the control group will receive PRF+standardized treatment
Beijing Tiantan Hospital
Beijing, China
RECRUITINGthe 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
Time frame: 1-month period
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)
Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Sleep quality measured by PSQI score(range 0-21, with higher scores indicating poorer sleep quality)
Time frame: 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
Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Analgesics consumption
the type of analgesics and analgesics consumption
Time frame: 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
Time frame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.