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

NCT ID: NCT07250867

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-02-28

Brief Summary

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.

Detailed 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.

Conditions

Orofacial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine Infusion Group

Group Type: EXPERIMENTAL

Lidocaine Intravenous Infusion

Intervention Type: DRUG

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.

Ketamine Infusion Group

Group Type: EXPERIMENTAL

Ketamine intravenous infusion

Intervention Type: DRUG

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.

Lidocaine-Ketamine Combination Group

Group Type: EXPERIMENTAL

Combined lidocaine and ketamine intravenous infusion

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed mustafa ahmed

Resident in Anesthesia, Intensive Care, and Pain Management Department, Faculty of Medicine, Assiut University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Lidocaine versus Ketamine

Identifier Type: -

Identifier Source: org_study_id