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Intranasal Esketamine-dexmedetomidine Combination in Patients With Postherpetic Neuralgia

8. november 2026 oppdatert av: Dong-Xin Wang, Peking University First Hospital

Efficacy of Intranasal Esketamine-dexmedetomidine Combination in Patients With Postherpetic Neuralgia: a Randomized, Double-blind, Active Drug-controlled Trial

Postherpetic neuralgia (PHN) is a chronic neuropathic pain syndrome suffered by patients with herpes zoster and often adversely affect patients' normal lives, leading to declines in sleep and quality of life. Ketamine/esketamine has been used for treatment of chronic pain but may produce adverse psychiatric reactions at slightly higher doses, including dissociative symptoms, hallucinations, and nightmares; the sedative effect of dexmedetomidine helps mitigate its psychiatric side effects. A previous study in orthopedic surgery patients also showed that dexmedetomidine combined with esketamine can significantly improve perioperative analgesia and sleep quality. The investigators hypothesize that intranasal administration of dexmedetomidine combined with esketamine in patients with postherpetic neuralgia can improve analgesic efficacy.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Postherpetic neuralgia (PHN) is a chronic neuropathic pain syndrome suffered by patients with herpes zoster. The typical feature of PHN is deep burning pain in the affected unilateral dermatome, often accompanied by stabbing pain and itching, persisting for more than 3 months after the initial onset of herpes zoster. The incidence of PHN among patients with herpes zoster is approximately 10-20%. The chronic pain symptoms of PHN often adversely affect patients' normal lives, leading to declines in sleep and quality of life. Approximately 50% of PHN patients have sleep disturbances. These ultimately affect cognitive function and mental health.

Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist and has long been used as a dissociative anesthetic. At subanesthetic doses, ketamine exhibits analgesic and antihyperalgesic effects. Guidelines recommend low-dose ketamine infusion for the treatment of chronic pain. Esketamine is the more potent right-handed enantiomer of ketamine, with stronger affinity for the NMDA receptor; its potency is approximately twice that of ketamine, and the incidence of adverse psychiatric reactions is lower in clinical use. Intranasal esketamine has been approved by the FDA for the treatment of adults with treatment-resistant depression and represents a more non-invasive route of administration.

Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative, analgesic, and anxiolytic effects. Dexmedetomidine acts on the locus coeruleus, inhibiting the release of norepinephrine from neurons in the locus coeruleus and the activity of the medullary-spinal descending neural pathways, thereby producing sedative and analgesic effects. In perioperative management, dexmedetomidine is widely used for postoperative adjuvant analgesia; it can also improve patients' sleep, producing a state resembling non-rapid eye movement sleep. Intranasal dexmedetomidine can be safely used in adults and children and is currently widely used for pediatric procedural sedation and preoperative medication.

Ketamine/esketamine can produce adverse psychiatric reactions at slightly higher doses, including dissociative symptoms, hallucinations, and nightmares; the sedative effect of dexmedetomidine helps mitigate its psychiatric side effects. A previous study in orthopedic surgery patients also showed that dexmedetomidine combined with esketamine can significantly improve perioperative analgesia and sleep quality. The investigators hypothesize that intranasal administration of dexmedetomidine combined with esketamine in patients with postherpetic neuralgia can improve analgesic efficacy.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100034
        • Peking University First Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥ 50 years.
  • Diagnosis of postherpetic neuralgia (PHN) requiring pharmacological analgesia, with a pain score ≥ 4 on the numerical rating scale (NRS).
  • Provision of written informed consent.

Exclusion Criteria:

  • Unsuitability for intranasal administration due to nasal disorders (e.g., rhinitis, nasal polyps, or nasal obstruction from any cause).
  • Inability to communicate owing to severe dementia, coma, or a language barrier.
  • History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
  • Previous diagnosis of sleep apnoea, or high risk of moderate-to-severe sleep apnoea on the STOP-Bang assessment, or body mass index > 30 kg/m².
  • History of hyperthyroidism or phaeochromocytoma.
  • Left ventricular ejection fraction (LVEF) < 30%; or sick sinus syndrome, severe sinus bradycardia (heart rate < 50 bpm), or second-degree or higher atrioventricular block without an implanted pacemaker; or systolic blood pressure < 90 mmHg before enrolment.
  • Severe hepatic impairment (Child-Pugh class C); severe renal impairment requiring dialysis; or any ongoing life-threatening condition (e.g., myocardial infarction, cerebrovascular accident, transient ischaemic attack, or coronary stenting within the previous 3 months; active myocardial ischaemia; severe valvular disease; or end-stage renal disease not receiving dialysis).
  • Hypersensitivity to dexmedetomidine and/or esketamine.
  • Participation in another clinical trial, or any other condition that, in the investigator's opinion, makes the patient unsuitable for inclusion.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: DEX-ESK group

For each administration: dexmedetomidine (1 spray = 0.05 ml = 25 μg) is administered as one spray into each nostril; after 1 minute, esketamine (1 spray = 0.05 ml = 1.25 mg) is administered alternately into each nostril, 4 sprays per nostril. Esketamine administration is repeated every 5 minutes until a total dose of 0.3 mg/kg is reached (using the number of sprays closest to the predetermined dose). If a dose is not tolerated, one administration may be omitted.

Administer once daily for 4 consecutive days, with the same administration method as above.
Legemiddel: Intranasal DEX-ESK combination

For each administration: dexmedetomidine (1 spray = 0.05 ml = 25 μg) is administered as one spray into each nostril; after 1 minute, esketamine (1 spray = 0.05 ml = 1.25 mg) is administered alternately into each nostril, 4 sprays per nostril. Esketamine administration is repeated every 5 minutes until a total dose of 0.3 mg/kg is reached (using the number of sprays closest to the predetermined dose). If a dose is not tolerated, one administration may be omitted.

Administer once daily for 4 consecutive days, with the same administration method as above.

Andre navn:
  • Intranasal dexmedetomidine and esketamine
Aktiv komparator: ESK group

For each administration: placebo (0.9% saline; 1 spray = 0.05 ml) is administered as one spray into each nostril; after 1 minute, esketamine (1 spray = 0.05 ml = 1.25 mg) is administered alternately into each nostril, 4 sprays per nostril. Esketamine administration is repeated every 5 minutes until a total dose of 0.3 mg/kg is reached (using the number of sprays closest to the predetermined dose). If a dose is not tolerated, one administration may be omitted.

Administer once daily for 4 consecutive days, with the same administration method as above.
Legemiddel: Intranasal ESK alone

For each administration: placebo (0.9% saline; 1 spray = 0.05 ml) is administered as one spray into each nostril; after 1 minute, esketamine (1 spray = 0.05 ml = 1.25 mg) is administered alternately into each nostril, 4 sprays per nostril. Esketamine administration is repeated every 5 minutes until a total dose of 0.3 mg/kg is reached (using the number of sprays closest to the predetermined dose). If a dose is not tolerated, one administration may be omitted.

Administer once daily for 4 consecutive days, with the same administration method as above.

Andre navn:
  • Intranasal placebo (normal saline) and esketamine

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sum of pain intensity difference (SPID) within 7 days after the first administration
Tidsramme: Within 7 days after the first administration

Follow-up time points: before each administration (Days 1, 2, 3, and 4 of enrollment; face-to-face follow-up); on Days 1, 2, and 3 after the last administration (Days 5, 6, and 7 of enrollment; telephone follow-up at the same time of day as drug administration).

Pain intensity: the patient's NRS pain score over the past 24 hours is recorded (0-10; 0 = no pain at all, 10 = the worst pain imaginable).

Sum of pain intensity difference (SPID): calculated as the sum of (baseline NRS score - NRS score at each scheduled daily follow-up) within 7 days after the first administration (i.e., 3 days after the last treatment).
Within 7 days after the first administration

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sum of pain intensity difference (SPID) during Weeks 2 to 12 after the first administration
Tidsramme: During Weeks 2 to 12 after the first administration

Follow-up time points: once weekly after the last administration until Week 12 of enrollment (Days 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, and 84 of enrollment; telephone follow-up).

Pain intensity: the patient's NRS pain score over the past 24 hours is recorded (0-10; 0 = no pain at all, 10 = the worst pain imaginable).

Sum of pain intensity difference (SPID): calculated as the sum of (baseline NRS score - NRS score at each scheduled weekly follow-up) during Weeks 2 to 12 after the first administration.
During Weeks 2 to 12 after the first administration
Change from baseline in ZBPI chronic pain and impact scores within 3 months after treatment
Tidsramme: Up to 3 months after the first administration

Follow-up time points: Days 7 and 14 after the first administration (telephone follow-up); Months 1, 2, and 3 after the first administration (Days 28, 56, and 84 of enrollment; telephone follow-up).

Severity of chronic pain and its impact on patients: assessed using the Zoster Brief Pain Inventory (ZBPI, Appendix 7). Pain severity is rated from 0 to 10, with higher scores indicating greater pain severity; pain interference is rated from 0 to 10 across 7 domains, with higher scores indicating greater interference with daily functioning.

Within 3 months after the first dose
Up to 3 months after the first administration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University First Hospital

Etterforskere

  • Hovedetterforsker: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. november 2027

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

8. november 2026

Først innsendt som oppfylte QC-kriteriene

8. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026R0576

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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