The Effects of Preemptive Multimodal Analgesic on Endodontic Pain.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Effects of Preemptive multimodal analgesia on post endodontic pain
研究概览
简要总结
A clinical trial comparing preemptive multimodal analgesics with placebo in the management of immediate and chronic post-endodontic pain. The study utilizes statistical methods such as chi-squared, T-tests, and regression analysis, accounting for multiple outcomes with the Bonferroni adjustment. Duloxetine hydrochloride and pregabalin, both available in Bangladesh, are evaluated as experimental drugs, while placebos are used to assess psychological effects on pain. All participants receive standard interventional treatments, with acetaminophen provided as needed, and ethical considerations are addressed according to international guidelines.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Consequently, triple binding is ensured (by the sit investigator, patient, and operator). The statistician in charge of the data analysis will also be blind.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient's aged 18 years more.
- •ASA physical status I-II.
- •Patient with the complain of pain originated from teeth and surrounding structure.
- •Preoperative pain severity is moderate to severe.
- •Patient can be able to make communication about their pain.
- •Patients give consent to attain this research.
- •Patients have others concomitant chronic pain.
- •Patients who will have non-surgical endodontic treatment.
- •Patients who will have non-surgical endodontic retreatment.
- •Patients who will have surgical endodontic treatment.
排除标准
- •Patient would not like to attain in research.
- •Patients have any medical condition those are contra indication for study drug.
- •ASA physical status III, IV, V.
- •Patient already under treated any anti convulsent drug.
- •Patient participant in other clinical trials.
- •Lack of motivation or poor adharence to study protocols.
- •Patient with Pregnancy
- •Severe organ dysfunction
- •Patient have Hepatitis B, and other cross infection disease like (HIV)
- •Uncontrolled comorbidities that patient do not fit for endodontic treatment.
- •Severe cognitive impaired patients.
- •History of certain cancers or severe hematological issues.
研究组 & 干预措施
Multimodal Analgesia
Preemptive Multi modal analgesic drug: Experimental group will be divided into 2 subgroups according to use of drug.
A. Pregabalin-acetaminophen. B. Duloxetine-Acetaminophen Pregabalin-acetaminophen: Before a half-hour endodontic treatment, patients in this group will receive a single dosage of 50 mg pregabalin and 500 mg acetaminophen. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
Duloxetine-Acetaminophen: Prior to a half-hour endodontic treatment, patients in this group will receive a single dosage of 500 mg of acetaminophen and 30 mg of Duloxetine. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
干预措施: Pregabalin- Acetaminophen (Drug)
Multimodal Analgesia
Preemptive Multi modal analgesic drug: Experimental group will be divided into 2 subgroups according to use of drug.
A. Pregabalin-acetaminophen. B. Duloxetine-Acetaminophen Pregabalin-acetaminophen: Before a half-hour endodontic treatment, patients in this group will receive a single dosage of 50 mg pregabalin and 500 mg acetaminophen. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
Duloxetine-Acetaminophen: Prior to a half-hour endodontic treatment, patients in this group will receive a single dosage of 500 mg of acetaminophen and 30 mg of Duloxetine. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
干预措施: Duloxetine- Acetaminophen (Drug)
Control
Placebo: Patient in this group will receive placebo drug before half an hour of operating procedure. If necessary, acetaminophen dosages of 500 mg will be administered three times a day and noted
干预措施: Pregabalin- Acetaminophen (Drug)
Control
Placebo: Patient in this group will receive placebo drug before half an hour of operating procedure. If necessary, acetaminophen dosages of 500 mg will be administered three times a day and noted
干预措施: Duloxetine- Acetaminophen (Drug)
结局指标
主要结局
Effects of Preemptive multimodal analgesia on post endodontic pain
时间窗: 6, 12, 24, 48, 72 hours
Primary Pain during endodontic treatment and the effectiveness of intervention will be evaluated at 6, 12, 24, 48, 72, and hourly intervals after the endodontic procedure. Treatment-related anaesthetic efficacy will be assessed using the VAS (Visual Analogue Scale; numerical value 0-10). During endodontic treatment, the level of pain will decide how effective the anesthetic is. The patient will be asked to rate the analgesic effects on a VAS (Visual Analogue Scale) scale by providing a numerical number 0-10. '0" are indicated no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= sever pain.
次要结局
- Mechanical Detection Threshold(baseline, 72 hours)
- Mechanical Pain Threshold(baseline, 72 hours)
- Mechanical Pain Sensitivity(baseline, 72 hours)
研究者
Prof. Dr. Md. Abu Saeed Ibn Harun
Professor
Chattogram International Dental College