Comparison of Safety, Efficacy, Patient Compliance and Cost-Effectiveness of Transdermal, Oral and Intramuscular Diclofe
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ORIGINAL ARTICLE
Comparison of Safety, Efficacy, Patient Compliance and Cost-Effectiveness of Transdermal, Oral and Intramuscular Diclofenac for Pain Control Following Oral Surgical Procedures Dipti Samal1 • Niranjan Mishra1 Rosalin Kar2 • R. H. Saipooja1
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Brundabati Meher1 • Indu Bhusan Kar1
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Received: 23 June 2019 / Accepted: 22 July 2019 Ó The Association of Oral and Maxillofacial Surgeons of India 2019
Abstract Purpose 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. Subjects and Methods A prospective, single-centre, multiarm 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, & Niranjan Mishra [email protected] Dipti Samal [email protected] Brundabati Meher [email protected] Indu Bhusan Kar [email protected] Rosalin Kar [email protected] R. H. Saipooja [email protected] 1
Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha, India
2
Department of Prosthetic Dentistry, SCB Dental College and Hospital, Cuttack, Odisha, India
adverse drug reactions experienced and overall global assessment for three post-operative days were recorded by the participants on a questionnaire. Results Transdermal and oral forms achieved similar analgesia on all 3 days. Injectable diclofenac had significantly better pain control on the second and third postoperative 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. Conclusion 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. Keywords Transdermal Oral Injectable diclofenac Oral surgery
Introduction Striving to achieve adequate post-operative analgesia that works conjointly with patient compliance has been an unremitting task for s
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