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

Assiut University

Status and phase: Not yet enrolling; Phase 2

Conditions: Orofacial Pain

Treatments: Drug: Lidocaine Intravenous Infusion; Drug: Ketamine intravenous infusion; Drug: Combined lidocaine and ketamine intravenous infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07250867

Lidocaine versus Ketamine

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- 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

Exclusion criteria

- Debilitating cardiac disease

Uncontrolled hypertension

Known allergies to lidocaine or ketamine

Severe renal or hepatic impairment

Pregnancy or breastfeeding

History of substance abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups

Lidocaine Infusion Group

Experimental group

Treatment:

Drug: Lidocaine Intravenous Infusion

Ketamine Infusion Group

Experimental group

Treatment:

Drug: Ketamine intravenous infusion

Lidocaine-Ketamine Combination Group

Experimental group

Treatment:

Drug: Combined lidocaine and ketamine intravenous infusion