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

ConditionOrofacial Pain

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.

Treatment groups

105 Participants

are divided into 3 treatment groups

Group A: Lidocaine Infusion GroupExperimental treatment 1 intervention

Group B: Ketamine Infusion GroupExperimental treatment 1 intervention

Group C: Lidocaine-Ketamine Combination GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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