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.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 105
- 主要终点
- Change in Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
- •Atypical facial pain
排除标准
- •- Debilitating cardiac disease
- •Uncontrolled hypertension
- •Known allergies to lidocaine or ketamine
- •Severe renal or hepatic impairment
- •Pregnancy or breastfeeding
- •History of substance abuse
研究组 & 干预措施
Lidocaine Infusion Group
干预措施: Lidocaine Intravenous Infusion (Drug)
Ketamine Infusion Group
干预措施: Ketamine intravenous infusion (Drug)
Lidocaine-Ketamine Combination Group
干预措施: Combined lidocaine and ketamine intravenous infusion (Drug)
结局指标
主要结局
Change in Visual Analog Scale (VAS) Pain Score
时间窗: Baseline, prior to 2nd infusion, prior to 3rd infusion, 1 month, 3 months, and 6 months after intervention
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.
次要结局
未报告次要终点
研究者
Mohamed mustafa ahmed
Resident in Anesthesia, Intensive Care, and Pain Management Department, Faculty of Medicine, Assiut University.
Assiut University
