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

NCT07250867 | Not Yet Recruiting Phase 2

• 1 other identifier: Lidocaine versus Ketamine
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orofacial Pain

Keywords

Orofacial Pain

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale (VAS) Pain Score

  Reduction in pain intensity as measured using the Visual Analog Scale (VAS), a 0-10 scale where 0 represents no pain and 10 represents the worst pain imaginable. The VAS will be assessed at baseline (before the first infusion) and at each follow-up visit (prior to 2nd infusion, prior to 3rd infusion, 1 month, 3 months, and 6 months after the intervention) to determine the effect of each treatment on resistant orofacial pain.

  Baseline, prior to 2nd infusion, prior to 3rd infusion, 1 month, 3 months, and 6 months after intervention

Study Arms (3)

Lidocaine Infusion Group

EXPERIMENTAL

Drug: Lidocaine Intravenous Infusion

Ketamine Infusion Group

EXPERIMENTAL

Drug: Ketamine intravenous infusion

Lidocaine-Ketamine Combination Group

EXPERIMENTAL

Drug: Combined lidocaine and ketamine intravenous infusion

Interventions

Lidocaine Intravenous Infusion 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.

Lidocaine Infusion Group

Ketamine intravenous infusion 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.

Ketamine Infusion Group

Combined lidocaine and ketamine intravenous infusion 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.

Lidocaine-Ketamine Combination Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- Debilitating cardiac disease
• Uncontrolled hypertension
• Known allergies to lidocaine or ketamine
• Severe renal or hepatic impairment
• Pregnancy or breastfeeding
• History of substance abuse

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Anesthesia, Intensive Care, and Pain Management Department, Faculty of Medicine, Assiut University.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11