Samal Dipti, Mishra Niranjan, Meher Brundabati, Kar Indu Bhusan, Kar Rosalin, Saipooja R H
Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.
Department of Prosthetic Dentistry, SCB Dental College and Hospital, Cuttack, Odisha India.
J Maxillofac Oral Surg. 2021 Mar;20(1):63-69. doi: 10.1007/s12663-019-01260-7. Epub 2019 Jul 25.
To evaluate transdermal diclofenac in terms of analgesic efficacy, safety, compliance and cost-effectiveness and to compare it with oral tablets and intramuscular (IM) injections following surgical removal of impacted mandibular third molars.
A prospective, single-centre, multi-arm parallel, randomized study on subjects undergoing extraction of impacted mandibular third molars was conducted between January 2016 and December 2017. The study included 90 participants, 30 in each group. Participants received the standard once daily (OD) dosages of diclofenac in each group for three post-operative days and were advised to consume paracetamol 500 mg as rescue analgesics if the pain was not alleviated. Outcome measures such as demographics, duration of surgery, post-operative pain, the number of rescue analgesics taken, adverse drug reactions experienced and overall global assessment for three post-operative days were recorded by the participants on a questionnaire.
Transdermal and oral forms achieved similar analgesia on all 3 days. Injectable diclofenac had significantly better pain control on the second and third post-operative days compared to tablets and on the third day compared to transdermal diclofenac. A higher number of rescue analgesics was consumed in oral group on day 1. Gastritis and vomiting were seen in 36.66% and 10% cases, respectively, in oral group. 100% of those in IM group had pain on injection. 6.6% complained of dry skin due to patch, while 3.33% had rash and pruritus. Transdermal group had better overall global assessment by patients with 16.67%, 46.67% and 20% participants reporting excellent, very good and good pain control, respectively. The cost in INR was maximum for the transdermal group.
Transdermal diclofenac is an excellent alternative to oral and parenteral routes of drug administration in oral surgical procedures with adequate analgesic efficacy, good compliance and fewer side effects.
评估双氯芬酸透皮贴剂在镇痛效果、安全性、依从性和成本效益方面的表现，并将其与拔除下颌阻生第三磨牙后口服片剂及肌内注射进行比较。
于2016年1月至2017年12月对接受下颌阻生第三磨牙拔除术的受试者开展了一项前瞻性、单中心、多组平行随机研究。该研究纳入90名参与者，每组30人。每组参与者在术后三天接受标准的每日一次双氯芬酸剂量，并被告知若疼痛未缓解可服用500毫克对乙酰氨基酚作为解救镇痛药。参与者通过问卷记录人口统计学信息、手术时长、术后疼痛情况、服用的解救镇痛药数量、所经历的药物不良反应以及术后三天的总体综合评估等结果指标。
透皮贴剂和口服剂型在所有三天内均达到相似的镇痛效果。注射用双氯芬酸在术后第二天和第三天的疼痛控制方面明显优于片剂，在第三天优于透皮贴剂。口服组在第1天服用的解救镇痛药数量更多。口服组分别有36.66%和10%的病例出现胃炎和呕吐。肌内注射组100%的人注射时疼痛。6.6%的人因贴片出现皮肤干燥，3.33%的人出现皮疹和瘙痒。透皮贴剂组患者的总体综合评估更好，分别有16.67%、46.67%和20%的参与者报告疼痛控制为优秀、非常好和良好。透皮贴剂组以印度卢比计算的成本最高。
在口腔外科手术中，双氯芬酸透皮贴剂是口服和非肠道给药途径的极佳替代方案，具有足够的镇痛效果、良好的依从性且副作用较少。
