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.
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.
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.
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.
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