EVALUATION OF PAIN CONTROL FOLLOWING THE ADMINISTRATION OF DICLOFENAC SODIUM BY TRANSBUCCAL PATCH VERSUS THE CONVENTIONAL PERORAL ROUTE AFTER ROUTINE DENTAL EXTRACTIONS. A COMPARATIVE SPLIT MOUTH PROSPECTIVE STUDY.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PAIN RELIEF
研究概览
简要总结
| Patients undergoing bilateral extractions are a standardized model to evaluate acute oral pain post-treatment, as they act as self-control with cross-over trials. |
Post tooth extraction to control pain and edema non-steroidal anti-inflammatory drugs are generally given. NSAIDs work well to control mild to moderate pain after tooth extraction.
However, due to first-pass metabolism, only about 50% of the absorbed diclofenac becomes systemically accessible when administered through the oral route. Furthermore, due to the elevated plasma concentration attained, oral diclofenac also carries the probability of significant adverse reactions, particularly in the gastrointestinal tract.
There always exists an alternate route to everything. Likewise, it’s applicable here also. The transbuccal route of administration of drugs is a novel way to deliver the drug directly to the site of our choice, bypassing the hepatic way of metabolism.
The transbuccal route of drug administration and incorporating it with diclofenac sodium gives contributing effects of sustained drug delivery, lower plasma concentration, and greater effects at the site with less drug dosage. However, the question of efficiency still exists.
The purpose of this study is to compare the efficacy of a transbuccal diclofenac sodium patch (TBDP) with oral diclofenac sodium for pain relief following extractions
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients aged between 18 to 65 years b) Without any systemic disease or drug allergy c) Patients indicated for posterior tooth extraction classified with similar difficulty index.
- •d) Interval between two extractions appointments should be at least a minimum of 7 days.
排除标准
- •a) Smokers (current or former) b) Alcoholics or narcotic abusers.
- •c) Condition of pregnancy or lactation.
- •d) Medically compromised patients.
- •e) Tooth with different difficulty index.
- •f) Tooth with any grade of mobility or periodontally compromised tooth.
- •g) Patients with the pathology associated with respect to their tooth indicated for extraction h) Patients not to be on any opioid analgesics and/or NSAIDs except diclofenac sodium.
结局指标
主要结局
PAIN RELIEF
时间窗: Pain is to be checked on the VAS scale after every 24 hours for 3 days post-extraction.
次要结局
- To check the efficacy of the patch in comparison to the conventional peroral route .(1 year)