Beijing Tiantan Hospital
Beijing, 100050, China
Location status: Recruiting
Location contact
Fang Luo, M.D
CONTACT
Lu Liu
CONTACT
NCT Number: NCT06890897
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, 100050, China
Location status: Recruiting
Fang Luo, M.D
CONTACT
Lu Liu
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Withdrawal criteria
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
Other names: Esketamine + PRF+standardized treatment
Patients in the control group will receive PRF+standardized treatment
Other names: PRF + standardized group
Time frame: 1-month period
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: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
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
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 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
the type of analgesics and analgesics consumption
Time frame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
intraoperative complications, PRF-related complications, Eskatamine-related complications
Contact information is provided by the study sponsor or research team.
Beijing Tiantan Hospital
Other
Effect of Intravenous Infusion of Esketamine Combined Pulsed Radiofrequency on Acute/Subacute Zoster-associated Trigeminal Neuralgia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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