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A comparative evaluation of diclofenac sodium transdermal patch, oral diclofenac sodium with intramuscular injections of diclofenac sodium in patients suffering from oral pain: A randomized control trial.

ABSTRACT: Background:Newer drug delivery systems such as transdermal patches using pain relieving or modifying agents emerged as a mainstream treatment protocol for management of pain on the outpatient basis. The administration of diclofenac 100 mg in the transdermal patch in the patients having dental pain due to periapical/periodontal infections was evaluated. Materials and Methods:Ninety patients of either gender, between 18 and 80 years were divided into 3 groups (Group A - oral medication, Group B - transdermal patch, Group C - intramuscular group). Patients at the Dental Department with pain from periapical/periodontal pathologies were explained about the procedure of analgesia. With written consent, 100 mg diclofenac sodium transdermal patches were prescribed to patients who opted their use in pain control for 2 consecutive days. A visual analog scale was provided for all patients assessing the pain intensity during the study. Results:Significant difference in the mean percentage reduction in visual analog scale (VAS) score among the three groups at day 1 and 2 (P < 0.001). Post hoc test showed that intramuscular (IM) and oral groups had significantly higher mean VAS score than patch group. Conclusion:Diclofenac administered through oral and IM routes showed significant improvement in pain relief when compared to the transdermal route. However, diclofenac transdermal patches have shown significant improvement in VAS score between the baseline and consecutive days and can be used in mild pain with lower adverse events.

SUBMITTER: Chaitanya NC

PROVIDER: S-EPMC5680648 | biostudies-literature | 2017 Jul-Sep

REPOSITORIES: biostudies-literature

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A comparative evaluation of diclofenac sodium transdermal patch, oral diclofenac sodium with intramuscular injections of diclofenac sodium in patients suffering from oral pain: A randomized control trial.

Chaitanya Nallan Csk NC Karunakar P P Garlapati Komali K Yeladandi Mounika M Bidari Pallavi P Soni Pratima P

International journal of pharmaceutical investigation 20170701 3

<h4>Background</h4>Newer drug delivery systems such as transdermal patches using pain relieving or modifying agents emerged as a mainstream treatment protocol for management of pain on the outpatient basis. The administration of diclofenac 100 mg in the transdermal patch in the patients having dental pain due to periapical/periodontal infections was evaluated.<h4>Materials and methods</h4>Ninety patients of either gender, between 18 and 80 years were divided into 3 groups (Group A - oral medicat ...[more]

PMID: 29184825

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Project description:PurposeSince electroporation (EP) can increase the permeability of biological membranes, we hypothesized that it offers an opportunity to enhance the transdermal delivery of drugs for intra-articular indications. Our aim was to compare the anti-inflammatory and analgesic efficacy of EP-combined topical administration of diclofenac sodium hydrogel (50 mg mL-1 in 230 µL volume) with that of an equivalent dose of oral (75 mg kg-1) and simple topical administration.MethodsArthritis was induced with the injection of 2% λ-carrageenan and 4% kaolin into the right knee joints of male Sprague Dawley rats. EP was applied for 8 min with 900 V high-voltage pulses for 5 ms followed by a 20 ms break. Drug penetration into the synovial fluid and plasma was detected by high-performance liquid chromatography. Leukocyte-endothelial interactions were visualized by intravital videomicroscopy on the internal surface of the synovium. Inflammation-induced thermal and mechanical hyperalgesia reactions, knee joint edema, and inflammatory enzyme activities were assessed at 24 and 48 h after arthritis induction.ResultsEP significantly increased the plasma level of diclofenac as compared with the topical controls 10 min after the 2% λ-carrageenan and 4% kaolin injection. Increased leukocyte-endothelial interactions were accompanied by joint inflammation, which was significantly reduced by oral and EP diclofenac (by 45% and by 30%, respectively) and only slightly ameliorated by simple topical diclofenac treatment (by 18%). The arthritis-related secondary hyperalgesic reactions were significantly ameliorated by oral and EP-enhanced topical diclofenac treatments. The knee cross-section area (which increased by 35%) was also reduced with both approaches. However, simple topical application did not influence the development of joint edema and secondary hyperalgesia.ConclusionThe study provides evidence for the first time of the potent anti-inflammatory and analgesic effects of EP-enhanced topical diclofenac during arthritis. The therapeutic benefit provided by EP is comparable with that of oral diclofenac; EP is a useful alternative to conventional routes of administration.

Project description:BackgroundDiclofenac is a nonsteroidal anti-inflammatory drug, available as a potassium salt (immediate release) or sodium salt (enteric coated to suppress dissolution in the stomach). This review updates an earlier review published in the Cochrane Database of Systematic Reviews (Issue 2, 2009) entitled 'Single dose oral diclofenac for acute postoperative pain in adults'.ObjectivesTo assess the analgesic efficacy and adverse effects of a single oral dose of diclofenac for moderate to severe postoperative pain, using methods that permit comparison with other analgesics evaluated in standardised trials using almost identical methods and outcomes.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, two clinical trial registries, and the reference lists of articles. The date of the most recent search was 9 March 2015.Selection criteriaRandomised, double-blind, placebo-controlled clinical trials of single dose, oral diclofenac (sodium or potassium) for acute postoperative pain in adults.Data collection and analysisTwo review authors independently considered studies for inclusion in the review, assessed risk of bias, and extracted data. We used the area under the pain relief versus time curve to derive the proportion of participants with at least 50% pain relief over six hours prescribed either diclofenac or placebo. We calculated the risk ratio (RR) and number needed to treat to benefit (NNT). We used information on the use of rescue medication to calculate the proportion of participants requiring rescue medication and the weighted mean of the median time to use. We also collected information on adverse effects.Main resultsThis update included three new studies, providing a 26% increase in participants in comparisons between diclofenac and placebo. We included 18 studies involving 3714 participants, 1902 treated with diclofenac and 1007 with placebo. This update has also changed the focus of the review, examining the effects of formulation in more detail than previously. This is a result of increased understanding of the importance of speed of onset in determining analgesic efficacy in acute pain.The largest body of information, for diclofenac potassium 50 mg, in seven studies, produced an NNT for at least 50% of maximum pain relief compared with placebo of 2.1 (95% confidence interval (CI) 1.9 to 2.5) (high quality evidence). There was a graded improvement in efficacy as doses rose from 25 mg to 100 mg, both for participants achieving at least 50% maximum pain relief, and for remedication within 6 to 8 hours. Fast-acting formulations (dispersible products, solutions, and softgel formulations) had a similar efficacy for a 50 mg dose, with an NNT of 2.4 (2.0 to 3.0). Diclofenac sodium in a small number of studies produced a lesser effect, with an NNT of 6.6 (4.1 to 17) for the 50 mg dose.Adverse event rates were low in these single dose studies, with no difference between diclofenac and placebo (moderate quality evidence).Authors' conclusionsDiclofenac potassium provides good pain relief at 25 mg, 50 mg, and 100 mg doses. Diclofenac sodium has limited efficacy and should probably not be used in acute pain.

Dataset Information

A comparative evaluation of diclofenac sodium transdermal patch, oral diclofenac sodium with intramuscular injections of diclofenac sodium in patients suffering from oral pain: A randomized control trial.

Publications

A comparative evaluation of diclofenac sodium transdermal patch, oral diclofenac sodium with intramuscular injections of diclofenac sodium in patients suffering from oral pain: A randomized control trial.

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