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Table of Contents   
ORIGINAL RESEARCH  
Year : 2020  |  Volume : 31  |  Issue : 1  |  Page : 53-56
The efficacy of transdermal and oral diclofenac for post-endodontic pain control: A randomised controlled trial


Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bangalore, Karnataka, India

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Date of Submission29-Mar-2017
Date of Decision09-Oct-2019
Date of Acceptance20-Nov-2019
Date of Web Publication02-Apr-2020
 

   Abstract 


Objective: The aim of the present study was to compare the effect of transdermal diclofenac patch against oral diclofenac for post-endodontic pain control. Materials and Methods: Thirty-two patients with symptomatic irreversible pulpitis in single-rooted premolar teeth of either arch were treated endodontically in a single visit by a single endodontist. Oral diclofenac (50 mg twice daily) for group I and transdermal diclofenac patch (100 mg once daily) for group II were administered as post-endodontic analgesics for two days. Visual analogue scale (VAS) chart was used to record pain intensity scores preoperatively and at intervals of 4, 8, 12 and 24 h postoperatively for 2 days. Paracetamol 650 mg tablets were provided as rescue medication. Results: There was a significant decrease in the postoperative pain intensity scores for both groups. The postoperative scores gradually decreased from day 1 to day 2 in both groups. Twelve out of sixteen patients who had received diclofenac tablets complained of gastric discomfort. Conclusion: Transdermal diclofenac patch was as effective as an oral diclofenac tablet and can be used as an alternative and effective analgesic for post-endodontic pain management, especially in patients with gastric discomfort.

Keywords: Diclofenac, post-endodontic pain, transdermal patch

How to cite this article:
Mangal S, Mathew S, Murthy B V, Hegde S, Dinesh K, Ramesh P. The efficacy of transdermal and oral diclofenac for post-endodontic pain control: A randomised controlled trial. Indian J Dent Res 2020;31:53-6

How to cite this URL:
Mangal S, Mathew S, Murthy B V, Hegde S, Dinesh K, Ramesh P. The efficacy of transdermal and oral diclofenac for post-endodontic pain control: A randomised controlled trial. Indian J Dent Res [serial online] 2020 [cited 2021 May 10];31:53-6. Available from: https://www.ijdr.in/text.asp?2020/31/1/53/281797



   Introduction Top


Post-endodontic treatment pain can be annoying to the patient and a challenge to the endodontist.[1],[2] Analgesics can be administered through a variety of routes and each has its own harmful effects. Transdermal drug delivery has been proven beneficial in reducing the frequency of dose, achieving target delivery, avoiding hepatic first-pass metabolism and consistent absorption of a drug over hours or days.[3],[4],[5] To date, no study has been performed to evaluate its efficacy for achieving post-endodontic analgesia.

Hence, the aim of the present study was to compare the effect of transdermal diclofenac patch against oral diclofenac for post-endodontic pain control.


   Materials and Methods Top


Source of data

Patients were recruited from the Department of Conservative Dentistry and Endodontics. Ethical clearance was obtained before the start of the study from the institutional ethical committee. The trial was registered in the Indian Clinical Trials Registry (CTRI/2017/03/008207).

Inclusion criteria

  • Patients belonging to both sexes between the age group of 18 and 65 years
  • Patients complaining of pain in single-rooted premolar teeth of either jaw and diagnosed as symptomatic irreversible pulpitis
  • Selected teeth showed intact lamina dura in intraoral periapical radiograph with no periapical radiolucency and absence of anatomical obstacles such as calcifications in the canals with no anticipated procedural difficulties
  • Selected teeth could be treated endodontically in one visit
  • Patients who gave informed consent for the study.


Exclusion criteria

  • Patients with hypersensitivity against diclofenac
  • Patients with a history of allergic reactions such as bronchospasm, shock, urticarial, etc., following the use of diclofenac or other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Patients with active stomach or duodenal ulceration within the last 6 months
  • Patients undergoing treatment with other NSAIDs or corticosteroids during the study period
  • Patients with a history of systemic diseases such as bronchial asthma, epilepsy, inflammatory bowel disease, severe liver or renal insufficiency, dengue fever, emotional and psychosomatic disorders
  • Pregnant and lactating women.


Study design

Patients who reported to the department with pain in posterior teeth were examined and 32 patients were selected according to the inclusion and exclusion criteria. It was a randomised, parallel-group trial. The procedure of the study and the probable side effects of the drugs being administered were explained to the patients. Written informed consent was obtained from all patients.

A brief case history of each patient was taken in order to rule out any medical conditions and hypersensitivity to diclofenac. A visual analogue scale (VAS) (a standard tool for rating pain) was explained and given to each of the patients and they were asked to self-assess their pain preoperatively.

Single-visit endodontic therapy was performed on the premolar tooth by a single endodontist, who was unaware as to which experimental group the patient will belong to (investigator blinding), thus removing any operator-induced bias from the study. After the completion of endodontic therapy, patients were allocated to two groups by a second investigator. Sequentially numbered, sealed, opaque envelopes were used as the method of concealment for the patients. The two parallel groups were: group I and group II (n = 16). Group I patients received post-treatment oral diclofenac tablet (Voveran 50 mg, Novartis India Limited) twice a day for 2 days. Group II patients received post-treatment transdermal diclofenac patch (Sandor Diclo-Touch, 100 mg) once a day for 2 days. The patch was placed on the right forearm of the patients. They were told to replace the patch with a new one and place it over left forearm on the next day. Four tablets of paracetamol (Paracip 500 mg, Cipla manufactures) were provided to each patient to be used as rescue medication if required. Patients were asked to record the intensity of pain on the VAS chart at 4, 8, 12 and 24 h postoperatively for 2 days. The number of rescue medication tablets taken, adverse effects such as gastric irritation, nausea, vomiting, diarrhoea, dizziness etc., experienced and any local irritation due to patch observed, if any, were advised to be recorded by the patients. They were asked to submit the chart for evaluation.

Statistical analysis

For statistical analysis, data were entered in Microsoft Excel and later analysed using SPSS version 20 (IBM Corp, Armonk, NY). Descriptive analysis was done to calculate the mean and standard deviation for continuous data. Mann-Whitney U test was performed to analyse the inter-group comparisons.


   Results Top


Pretreatment pain levels between treatment groups were recorded as more than three on the VAS chart. An evaluation of the pain intensity following endodontic therapy of premolars revealed that there was a significant decrease in the postoperative pain intensity scores. The scores gradually decreased from day 1 to day 2 with both the oral and transdermal diclofenac formulations. There was no statistical difference between the two intervention groups in relation to pain recorded using the VAS scale as P value was more than 0.05 for both the days at 4, 8, 12 and 24 h [Table 1].
Table 1: Inter-group comparison for post-endodontic pain management for the 2 postoperative days at different time intervals

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Twelve out of sixteen patients who had received diclofenac tablets reported with gastric discomfort, whereas none of the patients with the patch reported any discomfort [Table 2].
Table 2: Inter-group comparison for the occurrence of gastric discomfort

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None of the patients from either experimental group consumed paracetamol tablets as rescue medication. No local irritation was reported by the patients at the site of the transdermal patch application.


   Discussion Top


Patients commonly associate dental care with pain and experience of poorly managed pain related to dental treatment makes them maintain a strategic distance from or defer treatment.[6] The management of post-endodontic pain has always been a field for endless research with better formulations and modalities persistently replacing obsolete ones. NSAIDs are among the most well-known analgesic agents used to relieve postoperative dental pain. Their efficacy in reducing pain is due to inhibition of cyclo-oxygenases 1 and 2 (COX-1 and COX-2), key enzymes in the synthesis of prostaglandin (PG).[7] A significant amount of the drug administered orally is lost before being systemically absorbed owing to the first-pass metabolism. This leads to several adverse effects, particularly gastrointestinal related, which are dose-dependent.

Delivering medicine to the general circulation through the skin is seen as a desirable alternative to taking it by mouth or by parenteral route. Patients often forget to take their medicine, and even the most faithfully compliant become weary of gulping pills, especially if they should take a few every day. Additionally, bypassing the gastrointestinal tract (GIT) would obviate the GI irritation that frequently occurs and avoids partial first-pass metabolism by the liver, thereby ensuring steady absorption of the drug over hours or days.[8] Topical NSAIDs have subsequently cut out a niche for themselves as a remedial analgesic modality with established benefits and lower occurrence of unfavourable events.

A transdermal patch utilises a special membrane to control the rate at which the liquid drug contained in the reservoir within the patch can pass through the skin and into the bloodstream.[9] The relentless permeation of drugs across the skin allows for consistent plasma drug levels, often an objective of therapy.[7]

Diclofenac is an NSAID, taken or applied to reduce inflammation, as an analgesic and anti-pyretic agent. It has been routinely used as an analgesic following dental treatment. In the present study, it was administered in two forms: oral tablet (50 mg) to be taken twice a day and transdermal patch (100 mg) to remain at the site of application for 24 h. The 5 cm2 patch contained 100 mg of diclofenac diethylamine as the active agent that bestowed the sustained release of the drug.[7] As an organic acid, diclofenac is lipophilic, while its salts are water-soluble at neutral pH. The combination of these two properties renders easy penetration through cell membranes, including the synovial lining of diarthrodial joints and skin.[10] Studies performed by Cordero et al.[11],[12] reported that diclofenac had excellent transdermal penetration properties.

An evaluation of the intensity of pain following endodontic therapy of premolars revealed that there was a gradual decrease in the pain intensity scores from day 1 to day 2 with both the oral diclofenac tablets as well as with the transdermal patch. This finding is in accordance with the results of a previous study done by Dhanapal et al.[13] who evaluated the efficacy of a single dose of transdermal diclofenac patch against three oral doses per day as a pre-operative analgesic for endodontic pain management [Table 1].

In terms of safety, 12 out of 16 patients on oral diclofenac presented with gastric discomfort, whereas none of the patients with transdermal patch reported with any local or systemic discomfort [Table 2]. In contrast, when Agarwal et al.[14] used transdermal diclofenac patch for the attenuation of venous cannulation, they reported the occurrence of a localised erythematous rash at the site of application of a patch. The favourable result in the present study might be due to the fact that each successive application of the diclofenac patch was done at a different site. The safety profile of diclofenac patches has also been emphasised by Mason et al.[15] in their systematic review on the use of topical NSAIDs and by studies revealing the use of diclofenac transdermal patch in osteoarthritis[16] as well as in sports-related injuries.[17]

Limitations

  • This study was a patient-dependent study where the results were based on the subjective score values recorded by the patients. Thus, the participant's bias could not be eliminated from the study.
  • A single NSAID (diclofenac) was compared for two routes of administration (group I: oral and group II: transdermal patch) in the study. Further studies incorporating other pharmacological agents can be carried out.



   Conclusion Top


Within the limitations of the study, it was concluded that the transdermal diclofenac patch was as effective as an oral diclofenac tablet for post-endodontic pain management. Moreover, patients with transdermal patches did not experience any untoward discomfort. Hence, the transdermal diclofenac patch can be used as an alternative and effective analgesic for post-endodontic pain management, especially in patients with gastric problems.

Hence, this study opens vistas for future research.

Clinical trial registration: CTRI/2017/ 03/008207 at the Indian Clinical Trials Registry (Indian Council of Medical Research).

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Mohan S, Gurtu A, Singhal A, Mehrotra A. Management of post treatment endodontic pain. J Dent Sci Oral Rehabil 2013:8-9.  Back to cited text no. 1
    
2.
Jariwala S, Goel B. Pain in endodontics: Causes, prevention and management. Endodontology 2001;13:63-6.  Back to cited text no. 2
    
3.
Bachalli PS, Nandakumar H, Srinath N. A comparative study of diclofenac transdermal patch against oral diclofenac for pain control following removal of mandibular impacted third molars. J Maxillofac Oral Surg 2009;8:167-72.  Back to cited text no. 3
    
4.
Mitragotri S. Breaking the skin barrier. Adv Drug Deliv Rev 2004;56:555-6.  Back to cited text no. 4
    
5.
Subedi RK, Oh SY, Chun M-K, Choi H-K. Recent advances in transdermal drug delivery. Arch Pharm Res 2010;33:339-51.  Back to cited text no. 5
    
6.
Pozos-Guillen A, Martinez-Rider R, Aguirre-Banuelos P, Perez-Urizar J. Pre-emptive analgesic effect of tramadol after mandibular third molar extraction: A pilot study. J Oral Maxillofac Surg 2007;65:1315-20.  Back to cited text no. 6
    
7.
Bhaskar H, Kapoor P, Ragini. Comparison of transdermal diclofenac patch with oral diclofenac as an analgesic modality following multiple premolar extractions in orthodontic patients: A cross over efficacy trial. Contemp Clin Dent 2010;1:158-63.  Back to cited text no. 7
[PUBMED]  [Full text]  
8.
Saroha K, Yadav B, Sharma B. Transdermal patch: A discrete dosage form. Int J Curr Pharm Res 2011;3:98-108.  Back to cited text no. 8
    
9.
Bhowmik D, Chandira M, Jayakar B, Sampath KP. Recent advances in transdermal drug delivery system. Int J Pharm Tech Res 2010;2:68-77.  Back to cited text no. 9
    
10.
Rainsford KD, Kean WF, Ehrlich GE. Review of the pharmaceutical properties and clinical effects of the topical NSAID formulation, Diclofenac epolamine. Curr Med Res Opin 2008;24:2967-92.  Back to cited text no. 10
    
11.
Cordero JA, Alarcon L, Escribano E, Obach R, Domenech J. A comparative study of the transdermal penetration of a series of nonsteroidal antiinflammatory drugs. J Pharm Sci 1997;86:503-8.  Back to cited text no. 11
    
12.
Cordero JA, Camacho M, Obach R, Domenech J, Vila L. In vitro based index of topical anti-inflammatory activity to compare a series of NSAIDs. Eur J Pharm Biopharm 2001;51:135-42.  Back to cited text no. 12
    
13.
Dhanapal S, Sureshbabu NM. Efficacy of single dose of transdermal patch as a pre-operative analgesic in root canal treatment – A Randomized Clinical Trial. J Pharm Sci Res 2016;8:125-7.  Back to cited text no. 13
    
14.
Agarwal A, Dhiraaj S, Kumar A, Singhal V, Singh U. Evaluation of a diclofenac transdermal patch for the attenuation of venous cannulation pain: A prospective, randomised, double-blind, placebo-controlled study. Anaesthesia 2006;61:360-2.  Back to cited text no. 14
    
15.
Mason L, Moore RA, Edwards JE, Derry S, McQuay HJ. Topical NSAIDs for acute pain: A meta-analysis. Biomed Cent 2011;11:4-9.  Back to cited text no. 15
    
16.
Brühlmann P, Michel BA. Topical diclofenac patch in patients with knee osteoarthritis: A randomized, double-blind, controlled clinical trial. Clin Exp Rheumatol 2003;21:193-8.  Back to cited text no. 16
    
17.
Predel HG, Koll R, Pabst H, Dieter R, Gallacchi G, Giannetti B, et al. Diclofenac patch for topical treatment of acute impact injuries: A randomised, double blind, placebo controlled, multicentre study. Br J Sports Med 2004;38:318-23.  Back to cited text no. 17
    

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Correspondence Address:
Shivani Mangal
H. No. 92, Sector-19, Part-1, HUDA Colony, Dhand Road, Kaithal - 136 027, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijdr.IJDR_167_17

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