To Determine the Efficacy of a Single Dose of Dicloenac Transdermal Patch as a Post-operative Analgesic After Single-Visit Root Canal Treatment

INTRODUCTION

Endodontic post-treatment pain is the most notable problem faced by dental clinicians. The most likely sources of inter-appointment pain in endodontic treatment are associated with endodontic instrumentation, irritating irrigants, temporary restorations with high occlusion, intracanal medicaments and periapical contamination. Therefore, proper operative techniques are necessary for endodontic therapy to be successful, but so is the avoidance and control of post-operative pain.

The most widely used non-steroidal anti-inflammatory drug is diclofenac owing to its analgesic, anti-inflammatory and antipyretic properties. Diclofenac, when given orally, experiences a significant first-pass metabolism, with its bioavailability ranging from 54 to 90%. Currently, various manufacturers are marketing transdermal diclofenac patches, but little is known about their role in post-operative endodontic pain. Transdermal patches can be the choice of the analgesic modality of the near future with its equivalent or, at times, better efficacy over oral doses and better patient acceptance.

Hence, this in-vivo study was designed to investigate the efficacy of transdermal diclofenac patch (Nupatch® 200mg- Zydus Cadila).

MATERIAL AND METHODS

RESULTS

The mean values calculated for each group are given in Table 1. Intergroup comparison is shown in Table 2.

There was a decrease in pain intensity in patients in whom a transdermal patch was given, whereas, in patients in whom the patch was not given, there was no decrease in pain intensity from baseline to 48 hours. Also, there was no complaint of any side effects in the group in which the patch was given.

DISCUSSION

Dental therapy is often associated with pain, and patients who have experienced inadequately managed pain during dental care may avoid or postpone receiving treatment, which might make it difficult to treat them.^[1] The effective management of post-operative pain is helpful as it increases patient comfort and satisfaction and improves overall treatment outcomes.

NSAIDs are most commonly used and prescribed to relieve post-operative dental pain.^[2] Although NSAIDs are generally safe, they are usually prescribed in low doses and for short periods due to the potential for gastrointestinal side effects that can increase with higher doses. Because NSAIDs can penetrate tissues well and maintain high concentrations at sites of inflammation, they are often very effective for treatment. To address the limitations of oral NSAIDs, topical or transdermal drug delivery systems have been developed.^[3] Diclofenac patch was the first NSAID approved for the transdermal delivery method.^[4] Since several patients had discomfort within the first 24 hours of beginning root canal therapy, a 48-hour assessment period was selected for this study^.[5]

Transdermal patches are effective in both acute and chronic pain management with a lower incidence of side effects.^[6] It is preferably applied for 24 hours to produce rapid pain relief. The plasma levels of the patch (20–50 ng/mL) are lower compared to the oral route, but they are sustained for a longer duration.^[7] They function on crystal reservoir technology hence, continuous controlled drug delivery is ensured into the circulation.^[8] From the stratum corneum, the drug penetrates the epidermis, from there to the dermis through the network of local capillaries and finally to systemic circulation.^[4]

The efficacy of transdermal patch was evaluated by dividing the patients into two groups [Figure 1]:

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Figure 1:

Mean values of control and test group.

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Group 1 - Control Group: It comprised 200 patients with tooth pain, selected based on inclusion and exclusion criteria. Single-visit root canal treatment was performed. The transdermal patch was not given to the patients in this group.

Group 2 - Test Group: It comprised 200 patients with tooth pain and was finalized after evaluating the inclusion and exclusion criteria. Single-visit root canal treatment was done. After completion of the treatment, NuPatch was given to the patients in this group. The patch was applied by the clinician on the arm of the patient for a period of 48 hours.

Pain intensity was evaluated from the patients of both groups using VAS at baseline, 4, 8, 24 and 48 hours by making a telephone call to the patient or calling the patient to the department after 48 hours. In numerous previous studies, VAS has been used to assess pain following endodontic therapy. Although the VAS failure rate is typically between 4 and 11%, this can be prevented if the patient is properly informed.^[9] Mann–Whitney test was performed to compare both groups, revealing statistically significant differences.

Galer et al.^[10] concluded that the diclofenac patch was safe and effective in controlling pain after sports injury and had no systemic effect. In a research conducted by Predel et al.,^[11] diclofenac was administered in patch form for soft tissue injuries, and it was concluded that the patches were effective in treating blunt trauma. Funk et al.^[12] concluded that transdermal patches provided better pain relief in the early postoperative period after arthroscopic shoulder surgery as compared to oral diclofenac tablets. In a study performed by Bhaskar et al.,^[13] both an oral 150 mg diclofenac tablet and a transdermal diclofenac patch of 100 mg showed similar analgesic efficacy when used for post-dental extraction analgesia in orthodontic patients. It was also concluded that there was a 65% reduction in pain during the immediate 2 post-operative days in patients for whom transdermal patches were prescribed.

In the present study, there was no complaint of any gastric discomfort by the patients, as was also concluded by Mangal et al.^[2] Mason et al.^[14] in their study emphasized the safety profile of diclofenac patches and did not show any increased chances of renal failure or any serious gastrointestinal complications. However, in the study done by Tejaswi et al.,^[4] 3 out of 20; in the study by Dhanapal et al.,^[15] 4 out of 50; and in the study by Krishnan R et al.,^[16] 3 out of 30 patients complained of gastric discomfort.

A study conducted by Rajeswari et al.^[17] showed that there was no statistical difference at any time interval in post-operative pain management between two routes of diclofenac following dental implant placement. Another important concern, as noticed by Hitesh B et al.^[18] related to transdermal drug delivery methods, is that they take longer time of duration for onset and offset as compared to other drug delivery methods to control pain.

CONCLUSION

The Diclofenac patch is user-friendly, and its painless application process makes it an incredibly convenient option for patients undergoing endodontic procedures. Transdermal patches have advantages, but they cannot be used for acute pains due to slow onset and may cause skin irritation in some patients.

The true potential of transdermal diclofenac patches in various dental situations can only be clearly defined after conducting extensive clinical trials with a large sample size to demonstrate their effectiveness and safety. Further research is required to assess the use of transdermal pain relievers in other areas of dentistry and explore this method of delivery.