Comparing the efficacy of oral v/s intra nasal Tapentadol in the pain management after third molar extraction A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Tapentadol nasal spray is a superior analgesic than oral tapetatadol of zerodol p
研究概览
简要总结
This randomized control trial aims to compare the efficacy of oral and intranasal Tapentadol Hydrochloride for managing postoperative pain following third molar extractions. The study is being conducted in the Department of Oral and Maxillofacial Surgery at Meenakshi Ammal Dental College and Hospital, Chennai from 2023 to 2026 A total of 75 patients aged 18 to 35 years will be included divided equally into three groups of 25 participants each All patients will undergo transalveolar extraction of mesioangular impacted mandibular third molars of Class 2 Position B type under local anesthesia
Group A will receive the control medication consisting of Aceclofenac and Paracetamol twice daily for three days. Group B will receive Tapentadol Hydrochloride as an intranasal spray 45 mg every six hours for three days while Group C will receive oral Tapentadol Hydrochloride tablets 100 mg every six hours for three days All groups will be prescribed standard postoperative medications, including antibiotics and enzymes If adequate pain relief is not achieved Ketorolac will be provided as rescue analgesia
Pain will be assessed using a Visual Analogue Scale at intervals of 6 hours on postoperative day 0 day 1 and day 3 The scale categorizes pain from 0 indicating no pain to 10 indicating unbearable pain grouped into six levels of intensity Statistical analysis will be performed using SPSS software version 27 Descriptive data will be presented as mean and standard deviation while normality will be tested with the Shapiro Wilk test One way ANOVA with post hoc Tukey HSD test or Kruskal Wallis test with Dunn’s post hoc analysis will be applied as appropriate Chi square tests will be used for categorical data
The studys objective is to determine whether intranasal Tapentadol provides superior or comparable pain control to the oral formulation thereby offering a faster noninvasive and patient compliant alternative for postoperative pain management following third molar surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who consent to be part of the study.
- •3.Patients in ASA 1 category 4.Patients with mesioangular Impacted 3rd molars with class 2 position B (Pell and Gregory classification) indicated for trans-alveolar extraction under local anesthesia.
排除标准
- •1.Patients who do not consent to be part of the study 2.Patients with significant medical comorbidities eg. Diabetes, Hypertension, thyroid discrepancies, bronchial asthma, and other medical concerns 3.Patient allergic to active drug prescribed.
- •Tapendtadol 4.Patients with underlying nasal pathologies like allergic rhinitis, nasal polyps, and deviated septum. 5.Pregnant women or lactating mothers 6.Patients taking selective serotonin reuptake inhibitors (SSRIs) 7.Patients taking “opioid like medications” eg. Pentazocine, nalbuphimine 8.Acute alcoholism.
结局指标
主要结局
Tapentadol nasal spray is a superior analgesic than oral tapetatadol of zerodol p
时间窗: Visual Analog Pain Scale to be checked at 6hr post operatively 1st day post operatively and 3rd day post opeartively
次要结局
未报告次要终点
研究者
Dr Poorva Kulkarni
Meenakshi Academy of Higher education