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Intranasal Esketamine-dexmedetomidine Combination in Patients With Postherpetic Neuralgia

8. listopadu 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

80

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Beijing Municipality
      • Beijing, Beijing Municipality, Čína, 100034
        • Peking University First Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

50 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.

Ostatní jména:
  • Intranasal dexmedetomidine and esketamine
Aktivní komparátor: 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.
Lék: 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.

Ostatní jména:
  • Intranasal placebo (normal saline) and esketamine

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sum of pain intensity difference (SPID) within 7 days after the first administration
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sum of pain intensity difference (SPID) during Weeks 2 to 12 after the first administration
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Peking University First Hospital

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. listopadu 2026

Primární dokončení (Odhadovaný)

1. listopadu 2027

Dokončení studie (Odhadovaný)

1. května 2028

Termíny zápisu do studia

První předloženo

8. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

8. listopadu 2026

První zveřejněno (Aktuální)

13. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2026R0576

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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