Comparative evaluation of 50mg Tramadol, 0.75 Percent Ropivacaine, 2 Percent Lignocaine and 4 Percent Articaine in Patients undergoing Extraction of Maxillary Posterior Tooth: Unveiling Differences in Anesthetic Action, Pain Management, and Adverse Effects – A Double Blinded Randomized Clinical Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To assess the - Anesthetic action the onset of anesthesia and duration, The amount of anesthetic solution, Pain Management and Hemodynamic changes
研究概览
简要总结
Comparative evaluation of 50mg Tramadol, 0.75% Ropivacaine, Lignocaine Hydrochloride and 4% Articaine based on their success rates, amount of local anaesthetic agent delivered, onset, duration of action, Pre-operative, intra-operative pain and Post-operative pain and intensity, hemodynamic changes and adverse effects during maxillary tooth extraction.
Methodology
This study includes a total of 220 patients.
The sample size will be 55 patients per group.
Group A: Each patient will receive an initial dose of 1 dental syringe (1.8 mL) of drug A mixture of Tramadol HCl 50 mg.
Group B: Each patient will receive an initial dose of 1 dental syringe (1.8 mL) of drug A mixture of 0.75% Ropivacaine.
Group C: Each patient will receive an initial dose of 1 dental syringe (1.8 mL) of drug A mixture of 2% Lignocaine Hydrochloride.
Group D: Each patient will receive an initial dose of 1 dental syringe (1.8 mL) of drug A mixture of 4% Articaine.
The intra alveolar extraction procedure will be performed in all patients. The following parameters to be assessed pre operatively, intra procedure and post operatively are:
-
Amount of solution.
-
Onset and duration of action.
-
Pain
-
Sensory innervations.
-
Vitals.
-
Adverse effects.
Benefits of the Study : To wisely choose the right choice and dosage of drug for extraction of maxillary posterior tooth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1-Patients both males and females aged 20–70 years.
- •2-Firm tooth requiring extraction.
- •3-Patients indicated for extraction of maxillary posterior tooth.
- •4-ASA -I and II physical status patients.
- •5-Patients willing to participate in the study.
排除标准
- •1-Pregnant or lactating females.
- •2-Patients with a history of drug allergy.
- •3-Patients presenting with any systemic diseases.
- •4-Patients with recent history of infection for which medications were taken.
- •5-Mobile tooth.
- •6-Tooth or root stumps with periapical lesions and abscesses.
- •7-RCT – Treated tooth requiring transalveolar extraction or with secondary infection.
- •8-Deleterious personal habits.
- •9-Patients not willing to participate in the study.
结局指标
主要结局
To assess the - Anesthetic action the onset of anesthesia and duration, The amount of anesthetic solution, Pain Management and Hemodynamic changes
时间窗: Time duration of anaesthetic action will be measured after giving local anesthesia till the end of extraction procedure. | Pain management and Hemodynamic changes will be measured Pre operatively after 10 minutes giving local anesthesia. | Intra operatively during the procedure. | Post operatively after completion of tooth extraction till 10 minutes on the same day of extraction.
次要结局
- To assess the adverse effects of local anesthetics.(Time points are measured Pre operatively after 10 minutes giving local anesthesia.)
研究者
Dr N Akash
Thai Moogambigai Dental college and hospital Unit of DR. M.G.R Educational and Research institute