COMPARATIVE CLINICAL EVALUATION OF EFFECT OF PREOPERATIVE ORAL TRAMADOL AND KETOROLAC ON THE SUCCESS OF INFERIOR ALVEOLAR NERVE BLOCK IN PATIENTS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS -A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Evaluation of pain during access opening of Root canal treatment after giving inferior alveolar nerve block
研究概览
简要总结
Irreversible pulpitis is a persistent inflammatory condition of the pulp, symptomatic or asymptomatic caused by a noxious stimulus. (Pain is usually spontaneous or caused by hot or cold stimulus that persists for several minutes to hours, lingers after the removal of the stimulus). Pain is a significant symptom of irreversible pulpits makes the patient to seek treatment as quickly as possible. The best treatment option for irreversible pulpitis is pulp therapy which is nothing but endodontic access preparation and removal of pulpal tissue.
The inflamed pulp have high sensitivity, so the treatment process of induces pain, the pain of both pulpitis and treatment may combine leading the patient unco-operative during the treatment .So the local anesthesia is of most important. Inferior alveolar nerve block is given for the mandibular posterior teeth. The problem is always obtaining a satisfactory anesthetic effect is not possible, which would make patient not comfortable and clinician not confident during the treatment, especially when inflamed teeth are involved.
The possible reasons could be 1. low ph of inflamed tissues at the injection site and less conversion of the local anesthetic agent to their non ionized fat soluble form which is necessary to penetrate the nerve sheath. 2. Nerves within the inflamed tissue have altered resting potentials so that excitable threshold decreases. 3. Increased tetredotoxin receptors at the inflamed tissue .4.various anatomies such as accessory innervations and cross innervations .5.Tachyphylaxis of anesthetic agent.
If we can supplement the IANB with an analgesic there can be increased patient co-operation and clinician comfort. Many clinical studies have compared various preoperative analgesic medications to supplement IANB. Tramadol has been reported as an effective analgesic for post endodontic pain.
The aim of the study is to compare the effect of both oral Ketorolac and oral Tramadol for the success of IANB with current clinical evidence.
Source of data
• Patients visiting the Outpatient Department of Conservative Dentistry and Endodontics in Narayana Dental College and Hospital, Nellore, Andhra pradesh, with symptomatic irreversible pulpitis of the mandibular molars.
1. 70 teeth will be randomly assigned into 2 Groups with 35 in each Group.
2. Patients will be checked clinically and radio-graphically to diagnose symptomatic irreversible pulpitis.
3. Randomization and blinding of the tablets will be done. Either tramadol or ketorolac will be given to patient.
4. Patients will be asked to wait for an hour to start of access preparation.
5. IANB will be given before starting of the procedure.
Prior to the treatment patients demographic details and thorough history of presenting illness will be recorded. Patient is examined by visual analogue scale in which patient will place a pencil mark at on scale from 0 to 10 where 0 is no pain and 10 is worst pain possible. Randomization and blinding of the tablets will be done. Either of tramadol or ketorolac will be given to patient and asked to wait for an hour. Starting the procedure by giving inferior alveolar nerve block with 2ml of 2% lignocaine with 1 in 80,000 dilution of adrenaline will be given, after 15 minutes the procedure will be started.
During the treatment, while entering dentin, pulp and during removal of pulpal tissue if any pain felt by patient will be noted with visual analogue scale. If the patient requires second block or intra -ligamentary and intra- pulpal injections such patients will be excluded
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The patients have not taken any analgesics for at least 12 hours before enrollment in the study.
- •2.Patients with symptomatic irreversible pulpitis of any mandibular posterior teeth.
排除标准
- •1.Subjects under 18 years of age.
- •2.Known allergy, sensitivity, or contraindications to any opioid or non-opioid analgesic NSAIDs and local anesthetics.
- •3.History of active peptic ulcer within the preceding 12 months.
- •4.Pregnant or nursing women.
- •5.History of known or suspected drug abuse.
- •6.Patients who had taken NSAIDs within 12 hours before administration of the study drugs.
- •7.Patients with a history of significant medical conditions.
- •9.Patients having pain in more than 1 mandibular posterior teeth.
结局指标
主要结局
Evaluation of pain during access opening of Root canal treatment after giving inferior alveolar nerve block
时间窗: 15 minutes 30 minutes 45 minutes After administration of inferior alveolar nerve block
次要结局
- pain free root canal treatment(after 1hr)