Efficacy of Transdermal Diclofenac Patch and Ketoprofen Patch as Postoperative Analgesia after Extraction of First Premolars Bilaterally in Both Arches for Orthodontic Purpose: A Comparative Study

Abstract

Aim:

The aim of the study was to compare the efficacy of transdermal diclofenac patch with ketoprofen patch as postoperative analgesia after extraction of first premolars bilaterally in both arches for orthodontic purpose.

Materials and Methods:

A split-mouth technique was used in 52 patients with the age group of 15–25 years for extracting maxillary and mandibular first premolars bilaterally for orthodontic reason. A single ketoprofen patch was used after the extraction of premolars from first and fourth quadrant, whereas for the extraction of second and third quadrant premolars, diclofenac patch was used. All the extractions were performed under local anesthesia. The data were compiled and statistically analyzed using the student's t-test.

Results:

Mean visual analog scale score for diclofenac and ketoprofen patch was 2.05 (0.75) and 1.09 (0.3), respectively. Thirteen patients required additional medication (25%) and 1 (1.9%) patient with diclofenac and ketoprofen patch, respectively. No major complication or adverse effects were observed in any of the groups.

Conclusion:

Both diclofenac and ketoprofen transdermal patches are helpful in relieving pain after orthodontic extraction. Patients with diclofenac patch required more additional analgesia within 24 h compared to that with ketoprofen patch. None of the drugs showed any significant adverse effects and were well tolerated by the patients.

INTRODUCTION

Pain is a complex experience that consists of a specific sensation and the reactions elicited by that sensation.[1] It is one of the most common symptoms that are experienced after tooth extraction. The successful relief of pain to the patients undergoing any type of dental treatment is of the extreme importance to the dentist.[2] Pain relief offers considerable physiological benefits; therefore, monitoring pain relief has become a crucial postoperative quality measure. Dentist makes every effort to select an analgesic regimen that would provide profound analgesia without any adverse effects.[3]

Various drugs, opioids, and nonopioids have been employed for managing pain. These drugs can be administered by various routes (oral, transdermal, neuraxial, intravenous [IV], and regional). Recently, a concept of transdermal patches is gaining popularity as a new route to achieve analgesia. In this form of drug delivery system is a medicated adhesive patch is positioned over the skin to deliver a selected dose of medication through the skin into the bloodstream.[4]

This route of drug delivery is an alternate to oral route and might enhance patients' compliance and tolerance by reducing drug-related side effects. Other than that, it also avoids the pain associated with IV and intramuscular (IM) routes. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are also available in this form and can be administered systemically in low concentration, thus avoiding upper gastrointestinal complications such as gastric and peptic ulcers and dyspepsia.[5]

The present study's primary purpose was to compare the efficacy of transdermal diclofenac and ketoprofen patch as postoperative analgesia after extraction of first premolars bilaterally in both arches for orthodontic purpose. It was done by assessing pain through a visual analog scale (VAS) score and keeping a check on the total requirement of additional analgesia within the early 24 h of extraction. The secondary aim was to note down the adverse effects such as nausea and vomiting.

MATERIALS AND METHODS

Study design and sample

The present study was conducted in the department of oral surgery and the department of orthodontics after approval from the institutional ethical body and with patients' consent.

Inclusion criteria

• Patient with 15–25 years of age requiring extraction of first premolars for orthodontic intervention.

Exclusion criteria

• Patients not willing to give written informed consent

• Patients allergic to NSAIDS

• Patients with harmful habits such as pan/gutka chewing, smoking, and alcohol use

• Patients with periodontal and periapical pathology associated with premolars.

The study consists of 52 patients who underwent extraction of the first premolars in all four quadrants for orthodontic intervention. The random process was used to determine the side of extraction using the envelope with random numbers of teeth. Patients were not informed about the type of the patch applied to them to avoid any discrepancy in the study. Two percent of lignocaine hydrochloride with 1:200,000 adrenaline was used as an anesthetic solution for extraction, and extraction was performed under strict aseptic protocols. The same maxillofacial surgeon did all the extraction atraumatically using the forceps technique to eliminate operator-induced bias. The patients underwent extraction of maxillary and mandibular first premolars of the same side under local anesthesia at a single session, followed by the extractions of the other side of premolars a week later. The choice of analgesic was made using the coin toss method for each time. The head side represented the use of a transdermal diclofenac patch, and the other side represented the use of a ketoprofen patch.

A single-dose transdermal ketoprofen patch (20 mg/70 cm²; ketoprofen transdermal plasters, Demega Formulations Maharashtra, India) and diclofenac patch (200 mg/50 cm²; Nupatch, ZydusCadila Healthcare, Ahmedabad, India) were applied to each patient in the deltoid region consecutively immediately after tooth extraction.

All the study patients were given additional medication (tablet ibuprofen 400 mg in a tablet form) in a sealed envelope. They were supposed to take in case they experience any pain according to the study protocol. The name of the medication was not disclosed to the patient to avoid any discrepancies in the results. Any usage of the additional analgesia was telephonically recorded. Ibuprofen because of its effectiveness in dental pain was selected as the additional analgesia. Patients were given routine postextraction instructions.

Predicting factors

The outcomes of the study were measured by:

1. The intensity of pain in the initial 24 h after getting the teeth extracted

2. The requirement for additional analgesic within 24 h after extraction

3. The number of additional analgesic tablets taken within 24 h postoperatively, and

4. Any incidence of adverse or allergic reactions to transdermal patches.

Postoperative pain was evaluated using a 10-point VAS, and other parameters such as timing and dosage of the additional analgesia consumed and adverse reactions if any were recorded.

The data were compiled and subjected to statistical analysis. Paired student's t-test was used, and the level of significance was assumed at P = 0.05.

RESULTS

The present study consisted of total of 52 patients, and all of them (100%) were evaluated in follow-up phase. Of these 52 patients, 36 (70%) were female, and 16 (30%) were male, whereas 28 (54%) patients were between 15 and 20 years of age, and 24 (46%) patients were between 21 and 25 years.

The VAS score for pain intensity was recorded at 12 h after extraction. Any requirement of additional analgesia within the first 24 h and adverse effects due to patches were also recorded. Statistically significant difference was observed on comparing both the study groups [P < 0.00001; Table 1 and Graph 1]. For the diclofenac patch, the mean VAS score was 2.05 (0.75), whereas it was 1.09 (0.3) in the case of the ketoprofen patch. It was observed that additional medication requirement within the first 24 h after extraction and between the two extractions was less with ketoprofen patch. Graph 2 shows a comparison between other parameters. It shows that, in a group with diclofenac patch, 13 patients (25%) required additional analgesia compared to 1 (1.9%) with ketoprofen patch. No major complication or adverse effects were observed in any of the groups. Three patients with ketoprofen patch and two patients with diclofenac patch had mild fever following extraction.

Table 1.

Postoperative visual analog scale score after 12 h of extraction

Groups	Mean	SD	P
Ketoprofen patch	1.09	0.30	<0.00001
Diclofenac patch	2.05	0.75

SD: Standard deviation

Graph 1.

Comparing values of visual analog scale score in ketoprofen and diclofenac patch

Graph 2.

Comparing different variable in both the groups

DISCUSSION

Postoperative pain management remains an area for never-ending research with newer formulations and modalities that continuously replace present ones. Although various drugs as postoperative analgesia are administered through different routes, there is still a constant search for an ideal drug and route that can provide maximum analgesia and minimum side effects and improve patient compliance. The transdermal route is one of the safest, noninvasive, and most innovative drug delivery systems that provide sustained drug delivery. It needs a single application a day and is convenient to use. Besides, it also offers other advantages such as self-administration, increased bioavailability, and easy termination of medication, leading to better patient compliance. In this, the drugs are delivered across the skin in the form of patches to have an effect on the tissues adjacent to the site of application or to have an impact after distribution through the circulatory system.[5]

Many studies show that the efficacy of transdermal patches is more than oral tablets. Talnia et al.[4] evaluated the effectiveness of transdermal diclofenac patch and compared it to oral diclofenac tablet as analgesic following extractions in orthodontic patients. He concluded that transdermal diclofenac has better efficacy in managing the postoperative mild-to-moderate intensity pain in premolar orthodontic extraction with lower adverse effects. The same results were reported by Funk et al.[6] and Krishna et al.[7] they concluded that diclofenac patches provide significantly better analgesia and have fewer side effects as compared to the tablets in the early postoperative period. Metry et al. showed the transdermal ketoprofen patch is an effective and safe method for relieving pain after venous cannulation.[8]

Hence, the present study compares two drugs belonging to NSAIDs given through this innovative method in postoperative extraction patients. In our study, we found that the ketoprofen patch offers better pain control as compared to the diclofenac patch as the mean visual analog score [Table 1 and Graph 1] was less when the ketoprofen patch had been used. The same results were observed by Bhargava et al.[9] in his study. The results of this study are also in accordance with Jadhav et al.[10] who compared the two patches after orthognathic surgery and Verma et al.[5] in which the patches were compared following lower limb orthopedic surgery.

The need for additional analgesia in our study was mostly in patients on diclofenac patch 25% with 1.9% [Graph 2] patients as compared to the ketoprofen patch. Our results were consistent with a similar study done by Bhargava et al.[9] following orthodontic extraction, in which 20% of patients with diclofenac patch required additional analgesia; they showed that none of the patients from ketoprofen group needs the additional medication. Similar results were observed by Velásquez et al.,[11] who compares IM ketoprofen and IM diclofenac 75 mg after mandibular third molar extraction. They concluded that IM ketoprofen is more effective than IM diclofenac as preemptive analgesia.

This can be attributed to the fact that diclofenac retards prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1) and COX-2 with relative equipotency, whereas ketoprofen, other than inhibiting COX, also inhibits the lipoxygenase pathway of the arachidonic acid cascade, thereby reducing the synthesis of leukotrienes. It is a potent inhibitor of bradykinin and prevents the release of lysosomal enzymes by stabilizing the lysosomal membranes against osmotic damage, thus decreasing inflammatory reactions.[12]

No significant adverse effects were noticed after extraction and between two extractions in the present study [Graph 2]. The only symptom reported was mild fever, which was noted in both the groups. No allergic reactions or vomiting were observed among the study population. The results are supported by a study by Rani et al.[13] who compared the two patches in patients who underwent a hysterectomy. They concluded that transdermal patches are cause less discomfort as compared to traditional routes of drug delivery. Our results are also in accordance with Bhargava et al.[9] also who showed no adverse effects in both the groups. Transdermal patched caused a uniform absorption of the drug across the dermis, thus allowing for a consistent serum drug levels. Pharmacokinetic studies suggest that there is an increase in tissue concentration and low plasma concentration; thus, systemic effects remain low with this route.

Thus, our study shows that ketoprofen patch provided better analgesia than the diclofenac transdermal patch following orthodontic extraction.

CONCLUSION

Diclofenac and ketoprofen transdermal patches are helpful in relieving pain after orthodontic extraction. Patients with diclofenac patch required more additional analgesia within 24 h as compared to that with ketoprofen patch. None of the drugs showed any significant adverse effects and were well tolerated by the patients.

Further studies with a bigger sample size are needed to evaluate the efficacy of these drugs in various surgical procedures to support it as a sole method to achieve analgesia postoperatively.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.