Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Number of Participants With Local Anesthesia Efficacy
研究概览
简要总结
The goal of this clinical trial is to compare in Tramadol, Naproxen sodium and Placebo in participants presenting with irreversible pulpitis in their mandibular molar teeth.
The main question[s] it aims to answer are:
- Local anesthetic efficacy and .
- Postoperative pain. Participants will receive premedication treatments 60 minutes prior to the local anesthesia administration.
Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on Inferior alveolar nerve block efficacy and Postoperative pain.
详细描述
The adult participants who report in out-patient department (OPD) of Operative Dentistry at Dow International Dental College with the symptoms of irreversible pulpitis will be screened for the participation in the study. A detailed history will be taken which will be followed by clinical examination and complemented with sensibility testing with Endo Ice or electric pulp test. Radiographic analysis will also be done to confirm the diagnosis to assess for factors pertaining to exclusion and inclusion criteria. Verbal and written informed consent will be taken from all the participants.
Randomization: The participants will be randomly divided into 3 groups using a computer-generated randomization sequence (Microsoft Excel, Redmond, WA). The sequence was generated employing block randomization with an equal allocation ratio (1:1:1).
Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.
Blinding: operator, participant and outcome assessor will be blinded. A paramedical staff will be trained in giving medication to the participants.
Pain scores will be recorded by asking the participant to rate their pain on a scale ranging from 0 to 10 before medication and then after 15 minutes, 30 minutes and 60 minutes of administering the premedication. Pain score will also be recorded after 10 minutes of the administration of Inferior alveolar nerve block (IANBs) and buccal nerve block & during deroofing process of chamber opening. This step will serve as our primary outcome measure as anasthesia success rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Clinician and participants both will be blind to the medicine given to the participants. Participants will be given identical capsules by paramedical staff will be trained in giving medication to the participants. Outcome Assessor will be an intern who is not on research.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I and ASA II individuals who are between the ages of 18 and 60 years.
- •Patients who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
- •Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS= 1-10).
- •Mandibular permanent molars.
排除标准
- •Patients who had taken painkillers or narcotics in the previous 12 hours
- •Patients suffering from severe pain because of traumatic occlusion.
- •Teeth with extensive damage, calcified canals, root resorption, and an open apex.
- •Previously root canal treated teeth.
- •Medically compromised patients (ASA-III and above)
- •Those with special communication needs or who do not understand Urdu or English language.
- •Pregnant and lactating women
- •Individual patients who will be driving back alone
- •Patients who are allergic to the prescribed medicines
研究组 & 干预措施
Tramadol
Group A will receive premedication of Oral tramadol 100mg,
干预措施: Tramadol (Drug)
Placebo
Group C, will be the control group, and Surbex-Z will be given to these patients.
干预措施: Placebo (Drug)
Naproxen Sodium
Group B will receive premedication of oral naproxen sodium 550mg.
干预措施: Naproxen Sodium (Drug)
结局指标
主要结局
Number of Participants With Local Anesthesia Efficacy
时间窗: During access cavity preparation (deroofing)
Local anesthesia efficacy was defined as absence of pain (VAS score ≤ 3) during access cavity preparation (deroofing) after inferior alveolar nerve block. Pain was assessed using a 10-point Visual Analog Scale (0 = no pain, 10 = worst pain). Participants were categorized as having successful anesthesia if VAS ≤ 3 and failure if VAS \> 3.
次要结局
- Postoperative Pain(6,24,48,72 hours post operatively)
研究者
Tayyaba Tahira
Lecturer
Dow University of Health Sciences