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Safety and Efficacy of Lidocaine Versus Ketamine Infusion for Resistant Orofacial Pain
Sponsor: Assiut University
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2026-01
Completion Date
2027-02
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
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.
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.
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.