Postherpetic neuralgia
Conditions
Interventions
Experimental group:Esketamine hydrochloride nasal spray administration
Control Group:Placebo nasal spray administration
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =3 months, and pain score (NRS) >=4 points (to reduce interference from acute phase medications and ensure refractory cases); 3. Signed written informed consent and able to cooperate with treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous allergy to ketamine, esketamine, or esketamine hydrochloride; 2. Inability to perceive a bitter taste as confirmed by a bitterness perception test (test method: administer 2ml of saline containing the same type and concentration of bitter agent as the placebo via nasal spray (1ml per nostril), and the subject clearly reports no perception of bitterness); 3. Currently pregnant, breastfeeding, or planning pregnancy in the near future (female patients must confirm a negative pregnancy test); 4. Underlying diseases with poorly controlled symptoms: systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg (uncontrolled hypertension), heart rate >100 bpm (severe sinus tachycardia), rapid arrhythmias, New York Heart Association (NYHA) class III or above heart failure, untreated coronary artery disease; 5. History of neurological diseases: transient ischemic attack, stroke, or cerebral hemorrhage within the past 3 months, history of traumatic brain injury or neurosurgery, or presence of low or high intracranial pressure diseases; 6. History of psychiatric disorders: uncontrolled schizophrenia, bipolar disorder, severe anxiety, or depression (requires evaluation and confirmation by a psychiatrist); 7. History of vascular diseases: confirmed thoracic aortic aneurysm, abdominal aortic aneurysm, intracranial aneurysm, peripheral arterial disease, or arteriovenous malformation; 8. History of substance abuse: alcohol abuse, drug abuse (e.g., opioids, benzodiazepines, cocaine, etc.), or drug dependence within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Numerical Rating Scale (NRS) score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale (NRS) pain score at 90 days after administration;Incidence of neuralgia at 28 days and 90 days after administration (assessed by the ID-Pain scale);Sleep status at 28 days and 90 days after administration (assessed by the Pittsburgh Sleep Quality Index, PSQI);Negative emotional status at 28 days and 90 days after administration (assessed by the State-Trait Anxiety Inventory [STAI], Fear of Pain Questionnaire, [FOP]]and Pain Catastrophizing Scale, [PCS]);Numerical Rating Scale (NRS) pain score at 2 hours after each administration;Numerical Rating Scale (NRS) pain score at 2 hours after each administration;Baseline fMRI ;fMRI 90 days after administration;Incidence of adverse events after administration and during follow-up;Drug adverse reaction scores after administration and during the follow-up period (SERSDA scale); | — |
Countries
China
Contacts
Public ContactXin Xin
Peking University First Hospital
Outcome results
None listed