Comparison of Safety, Efficacy, Patient Compliance and Cost-Effectiveness of Transdermal, Oral and Intramuscular Diclofenac for Pain Control Following Oral Surgical Procedures.

Abstract

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 500mg 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 3days. 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.