Safety and Efficacy of Lidocaine Versus Ketamine Infusion for Resistant Orofacial Pain

Официальное название

Safety and Efficacy of Lidocaine Versus Ketamine Infusion or Both Together as a Treatment Modality in Patient With Resistant Orofacial Pain; Double Blinded Randomized Study.

Обзор

A prospective, randomized, double-blind clinical trial comparing the safety and efficacy of intravenous lidocaine, ketamine, and their combination as treatment options for patients suffering from treatment-resistant orofacial pain. The study measures pain reduction primarily using the Visual Analog Scale and evaluates safety and tolerability over a follow-up period of 6 months.

Подробное описание

This study aims to assess and compare the analgesic efficacy and safety profiles of intravenous lidocaine, ketamine, and a combined infusion of both in adult patients with orofacial pain that is resistant to conventional medical or interventional therapies. Using a randomized, double-blind design, 105 patients will be allocated equally into three parallel groups receiving either lidocaine infusion (5 mg/kg over 4 hours), ketamine infusion (0.3 mg/kg over 4 hours), or a combination infusion of lidocaine (2.5 mg/kg) and ketamine (0.15 mg/kg) over 3 consecutive weeks. Primary efficacy will be assessed by changes in pain intensity measured by the Visual Analog Scale (VAS) from baseline through follow-up visits at the 2nd and 3rd infusions, and 1, 3, and 6 months post-treatment. Secondary outcomes include cortisol level changes, depression assessment via PLAT-Q, and adverse events monitored during and after infusions. Strict inclusion and exclusion criteria will ensure patient safety and reliability of results. Data will be analyzed using one-way ANOVA and repeated measures ANOVA for continuous variables with significance set at p \< 0.05.

Вмешательства

• Препарат Lidocaine Intravenous Infusion
  Participants receive a slow intravenous infusion of lidocaine at a dose of 5 mg/kg (not exceeding 500 mg in total), diluted in 0.9% saline and administered over a 4-hour period, once weekly for three consecutive weeks. Continuous monitoring of cardiovascular and neurological status is provided during and after infusion to assess for efficacy and safety in cases of treatment-resistant orofacial pain.
• Препарат Ketamine intravenous infusion
  Participants receive a slow intravenous infusion of ketamine at a dose of 0.3 mg/kg, diluted in 0.9% saline and delivered over 4 hours, once weekly for three consecutive weeks. The procedure includes monitoring for cardiovascular and CNS adverse effects. This intervention aims to evaluate the analgesic and safety profile of ketamine in patients with persistent orofacial pain unresponsive to standard therapies.
• Препарат Combined lidocaine and ketamine intravenous infusion
  Participants receive a single intravenous infusion containing both lidocaine (2.5 mg/kg) and ketamine (0.15 mg/kg) diluted in 0.9% saline, administered over 4 hours, once weekly for three consecutive weeks. This intervention is designed to determine whether the combination of lidocaine and ketamine provides synergistic analgesic effects and improved tolerability compared to either drug alone in treating resistant orofacial pain.

Первичные конечные точки

• Change in Visual Analog Scale (VAS) Pain Score [Срок оценки: Baseline, prior to 2nd infusion, prior to 3rd infusion, 1 month, 3 months, and 6 months after intervention]

Критерии участия

Критерии включения

\- Adults aged > 18 years

Resistant orofacial pain patients with failed medical or interventional treatment

Diagnosed with one or more of the following:

Trigeminal neuralgia

Temporomandibular joint (TMJ) dysfunction

Malignant otitis externa

Migraine

Atypical facial pain

Критерии исключения

\- Debilitating cardiac disease

Uncontrolled hypertension

Known allergies to lidocaine or ketamine

Severe renal or hepatic impairment

Pregnancy or breastfeeding

History of substance abuse

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07250867 · Lidocaine versus Ketamine

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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