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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 34  |  Issue : 3  |  Page : 263-267

Assessment of lornoxicam as a mouth dissolving film in management of post extraction pain-A randomized control trial


Department of Oral Medicine and Radiology, JSS Dental College and Hospital, JSS Academy of Higher Education and Research, Mysore, Karnataka, India

Date of Submission08-Apr-2022
Date of Decision27-Aug-2022
Date of Acceptance05-Sep-2022
Date of Web Publication26-Sep-2022

Correspondence Address:
K P Mahesh
Department of Oral Medicine and Radiology, JSS Dental College and Hospital, JSS Academy of Higher Education and Research, Mysore - 570 015, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jiaomr.jiaomr_119_22

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   Abstract 


Background: Mouth dissolving film (MDF) is a fast-dissolving drug delivery system that provides a practical means to administer drugs not just to special populations with swallowing difficulties but also to the general public. MDFs are novel dosage forms that dissolve and disintegrate quickly within the mouth. Aim: To assess the efficacy of lornoxicam mouth dissolving film as a potent analgesic and drug delivery system and compare it with the aceclofenac tablet in the management of post-extraction pain. Methodology: The study group comprised 60 subjects of either sex of age group 20–50 years who were divided into an experimental group (group A) and a control group (group B). Group A was administered lornoxicam MDF and group B was administered aceclofenac tablets. Pre-treatment and post-treatment pain assessments were recorded using a visual analog scale (VAS) and an oral pain scale (OPS). Results: In a comparison of the mean value of pre-treatment VAS and VAS after 24 h, the percentage of pain reduction in group A was 86.66%, and in group B was 75%. When comparing the mean value of pre-treatment OPS and OPS after 24 h, the percentage of pain reduction in group A was 93.33% and in group B was 75%. These results were statistically significant, with a P value of 0.00 in both groups. Conclusion: Lornoxicam as an MDF showed promising results in managing post-extraction pain. The potential delivery of lornoxicam through the MDF was safe, with better patient compliance, and no reported cases of adverse effects.

Keywords: Aceclofenac, drug delivery system, lornoxicam, pain measurement, post-operative pain


How to cite this article:
Vijayan M A, Mahesh K P, Patil K. Assessment of lornoxicam as a mouth dissolving film in management of post extraction pain-A randomized control trial. J Indian Acad Oral Med Radiol 2022;34:263-7

How to cite this URL:
Vijayan M A, Mahesh K P, Patil K. Assessment of lornoxicam as a mouth dissolving film in management of post extraction pain-A randomized control trial. J Indian Acad Oral Med Radiol [serial online] 2022 [cited 2022 Dec 10];34:263-7. Available from: http://www.jiaomr.in/text.asp?2022/34/3/263/356947




   Introduction Top


Mouth dissolving films (MDFs), are novel drug dosage forms that provide a practical means to administer drugs to special populations with swallowing difficulties as well as to the general public.[1] MDFs can be easily placed on the tongue or any other oral mucosal sites of the patient. MDF is instantaneously moistened by saliva, hydrates quickly, adheres to the application site, and swiftly disintegrates and dissolves, releasing the drug for mucosal absorption.[1] The clinical relevance of our study is pain control with reduced gastric irritation. The compliance with the drug was extremely satisfactory. The need of the study is to evaluate the pain control efficiency in post-extraction patients.


   Materials and Methods Top


Study design

Depicted with flowchart [Figure 1].
Figure 1: Flowchart depicting a summary of study design

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Methodology

The methods used were in compliance with the Helsinki Declaration of 1975, as amended in 2000, and with the ethical standards of the responsible committee on human experimentation. Ethical clearance was obtained from the Institutional Ethics Committee before conducting the study (IEC No: 66/2019-JSSDCH, Mysore) given by IEC JSS dental college, Mysore). This was a randomized control trial performed on 60 adult patients of either sex of age group 20–50 years, selected by random sampling. Sample collection was done for 15 months.

Sample size estimation formula:



Subjects were divided into two groups: the experimental group (group A) and the control group (group B). Formulation and characterization of lornoxicam MDF (4 mg) were done in the Department of Pharmaceutics under the standard protocol. Aceclofenac tablets were purchased from an authorized pharmacy with a receipt. Written informed consent was obtained from study subjects. A Clinical examination was carried out, and findings were recorded in an individual proforma.

Eligibility criteria

Inclusion criteria

  • Adult patients of either sex, of age group 20–50 years.
  • Patients who were diagnosed with grossly decayed teeth not associated with periapical pathology or periodontally compromised teeth were indicated for extraction and orthodontic extraction.


Exclusion criteria

  • Subject with allergic history to any non-steroidal anti-inflammatory drugs.
  • Pregnant or lactating women.
  • Medically compromised subjects.


The subjective intensity of pain was measured with a visual analog scale (VAS) and oral pain scale (OPS). VAS consists of a 10-mm line with two extreme ends, representing the limits of pain a subject may experience. 'No pain' is depicted at the left end of the line, whereas the worst pain is indicated at the right end.[2]

An OPS evaluates pain using a 4-point scale. Subjects should indicate the pain at each evaluation with 0 = none or no discomfort, 1 = mild discomfort, 2 = moderate or marked discomfort, and 3 = severe or marked discomfort that lasted for more than 10 s.[3]

Group A (Experimental group)

Lornoxicam film was delivered to the patients in the experimental group 1 h after extraction [Figure 2]. Four Lornoxicam strips were given to the patient. Pre-treatment VAS and OPS were recorded before administering the lornoxicam film. The first tablet was taken after 1 h of extraction. Post-treatment assessment of VAS and OPS was done 10 min after delivering the film, followed by 30 min and 1 h. Patients were retained in the clinic for 1 h for pain assessment. Further pain assessment after 2 h and 24 h was done by telephone.
Figure 2: (a) Mouth dissolving film of lornoxicam (b) Placement of lornoxicam mouth dissolving film on the dorsum of the tongue

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Group B (Control group)

Aceclofenac tablet was administered to the patients in the control group 1 h after extraction. Four tablets were given to patients. Pre-treatment VAS and OPS were recorded before administering the tablet. The first tablet was taken after 1 h of extraction. Post-treatment assessment of VAS and OPS was done 10 min after delivering the tablet, followed by 30 min and 1 h. Patients were retained in the clinic for 1 h for pain assessment. Further assessment after 2 h and 24 h was done by telephone.

The collected data were analyzed, tabulated, and subjected to statistical analysis.

Statistical analysis

Statistical analysis was performed using the SPSS software version 22.0. The mean value, standard deviation (SD), P value, and t-value were calculated for group A and group B. A comparison of mean VAS and OPS scores was carried out between males and females. Collected data were subjected to descriptive statistics, Pearson's Chi-square test, and independent sample tests. A P value of less than or equal to 0.05 was considered to be statistically significant.


   Results Top


VAS analysis

Group A:

In group A, 15, 13, and 2 subjects showed pre-treatment VAS scores of 7, 8, and, 9, respectively. After 24 h, 15, 9, 4, and, 8 subjects showed VAS scores of 0, 1, 2, and 8, respectively. The mean use of pre-treatment VAS among group A subjects, independent of gender, was 7.56. When post-treatment pain intensity was recorded, mean values after 10 min, 30 min, 1 h, 2 h, and 24 h were 6.56, 5.16, 3.46, 2.30, and 1, respectively. A significant drop in the pain scale was noted between pre-treatment and post-treatment VAS scores. The mean values of pre-treatment VAS, and VAS at 10 min, 30 min, 1 h, 2 h, and 24 h when subjected to the Pearson Chi-square, the P values obtained were 0.007, 0.000, 0.004, 0.056, 0.00, and 0.00, respectively. These results were statistically significant except for VAS at 1 h, which was statistically non-significant [Table 1].
Table 1: Table depicts descriptive statistics of VAS analysis in group A and group B along with the Pearson Chi.square test for comparison of changes between the groups

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Group B:

In group B, 2, 10, 7, 9, 1, and 1 subjects showed pre-treatment VAS scores of 10, 9, 8, 7, 6, and 5, respectively. After 24 h, 3, 7, 9, 10, and 1 subjects showed VAS scores of 0, 1, 2, 3, and 5, respectively. The mean value of pre-treatment VAS was 8. When post-treatment pain intensity was recorded, mean values after 10 min, 30 min, 1 h, 2 h, and 24 h were 7.96, 7.63, 6.70, 5.86, and 2, respectively. The mean values of pre-treatment VAS, and VAS at 10 min, 30 min, 1 h, 2 h, and 24 h when subjected to the Pearson Chi-square test, the P values obtained were 0.004, 0.013, 0.092, 0.053, 0.053, and 0.040, respectively. These results were statistically significant except for VAS at 30 min, which was statistically non-significant.

On analysis of VAS, results obtained were subjected to the Pearson Chi-Square test to compare the changes in group A and group B. Interpretation of the results revealed that group A and group B were statistically significant, with a P value of 0.00 in both the groups and Chi-square values (χ2) of 273.80 and 252.268, respectively.

When comparing the mean value of pre-treatment VAS and VAS after 24 h, the percentage of pain reduction in group A was 86.66% and in group B was 75% [Figure 3].
Figure 3: Line graph depicting mean VAS scores in group A and group B

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OPS analysis

Group A:

In group A, all subjects (n = 30) had severe discomfort before treatment. After 24 h of treatment, 25 subjects had no discomfort, 4 had mild discomfort, and 1 had moderate discomfort. The mean value of pre-treatment OPS was 3. Mean values of post-treatment OPS at 10 min, 30 min, 1 h, 2 h, and 24 h were 2.63, 2, 1.4, 0.96, and 0.2, respectively. A significant difference in pain scale was noted between pre and post-treatment. Results of OPS at 10 min, 30 min, 1 h, 2 h, and 24 h, when subjected to the Pearson Chi-square test, were statistically significant with P values of 0.00, 0.00, 0.001, 0.00, and 0.00, respectively [Table 2].
Table 2: Table depicts descriptive statistics of OPS analysis in group A and group B along with the Pearson Chi-square test for comparison of changes between the groups

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Group B:

In group B, 2 subjects had moderate discomfort and 28 subjects had severe discomfort before the treatment. After 24 h of treatment, 5 subjects had no discomfort, 24 had mild discomfort, and 1 had moderate discomfort. The mean value of the pre-treatment OPS was 2.93. Mean values of post-treatment OPS at 10 min, 30 min, 1 h, 2 h, and 24 h were 2.9, 2.83, 2.56, 2.2, and 0.86, respectively. A significant difference in the pain scale was noted between pre-treatment and post-treatment. Results of OPS at 10 min, 30 min, 1 h, 2 h, and 24 h, when subjected to the Pearson Chi-square test, were statistically significant with P values of 0.00, 0.00, 0.001, 0.00, and 0.00, respectively.

To summarize, on analysis of OPS, the results obtained were subjected to the Pearson Chi-Square test to compare the changes in group A and group B. Interpretation of results revealed that group A and group B were statistically significant, with a P value of 0.00 in both the groups and a Chi-square value (χ2) of 246.34 and 202.366, respectively.

When comparing the mean value of pre-treatment OPS and OPS after 24 h, the percentage of pain reduction in group A was 93.33% and in group B was 75% [Figure 4].
Figure 4: Line graph depicting mean OPS scores in group A and group B

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   Discussion Top


For systemic drug delivery, transmucosal methods provide key benefits over oral administration.[4] These benefits include avoiding pre-systemic clearance in the gastrointestinal tract, preventing first-pass metabolism, and having low enzyme activity.[4]

To tackle these flaws, researchers have developed novel drug delivery systems called mouth-dissolving tablets and films.[5]

In a variety of clinical trials, Misal et al.[6] demonstrated the efficacy of lornoxicam for postoperative pain management associated with dental operations.

A study was conducted by Nidhi et al.[7] on the fabrication of transmucosal patches for dental procedures loaded with an anesthetic and analgesic, comparing results with our study.

In a preliminary study by Annigeri et al.,[8] they found a significant decrease in dental pain with the use of meloxicam mucoadhesive patches with no side effects. From baseline to the score observed after 30 min, pain level decreased significantly, which was found to be showing similar results to our study.

In a recent study by Pattewar et al.,[9] they developed a sublingual self-micro emulsifying MDF, which disintegrated in 26 s. The present study also showed similar results.

In another study by Thriveni et al.[10] in 2019, a transmucosal mucoadhesive patch of lornoxicam was developed. Pain assessment was done using the VAS scale. The study concluded that lornoxicam as a transmucoadhesive patch for managing odontogenic pain is suitable, safe, and effective. The present study shows comparative results to our study.

A study was conducted by Oncul et al.[11] in 2011, wherein paracetamol, diclofenac sodium, and lornoxicam were administered. At 12 h, pain scales in the lornoxicam group were considerably lower than in the diclofenac sodium and paracetamol groups. In comparison with a previous study, the result in the present study also implied that group A treated with lornoxicam MDF showed better pain reduction than the group treated with aceclofenac tablet until 24 h after drug delivery.

When analyzing the results of the current study, when pre-treatment and post-treatment VAS scores (after 24 h) were taken into consideration, the percentage of pain reduction in the group was 86.66%. In group B, the percentage of pain reduction was 75%. When comparing the mean value of pre-treatment OPS and post-treatment OPS (after 24 h), the percentage of pain reduction in group A was 93.33% and 75% in group B.


   Conclusion Top


There has been increasing research to develop novel routes for the administration of NSAIDs to provide individualized treatment for patients with a greater safety margin while maintaining the efficacy of analgesia and pain management. MDFs are one of those routes that are rapidly gaining popularity as a potential drug delivery system, due to their better patient compliance, ease of administration, and improved bioavailability.

The goal of the present study was to assess the efficacy of lornoxicam as an MDF in reducing post-extraction pain in comparison with aceclofenac tablets. A VAS and an OPS were used for the pre-treatment and post-treatment assessment of pain.

Thus, it can be concluded that lornoxicam as an MDF showed promising results in managing post-extraction pain. The potential delivery of lornoxicam through MDFs was safe, with better patient compliance and no reported cases of adverse effects.

Key message

The ultimate goal of any drug delivery system is the successful delivery of the drug to the body; however, patient compliance must not be overlooked. Fast-dissolving drug delivery systems, such as MDF, offer a convenient way of dosing medications, not only to special population groups with swallowing difficulties, such as children and the elderly but also to the general population. MDFs are novel dosage forms that disintegrate and dissolve within the oral cavity. Intra-oral absorption permits rapid onset of action and helps bypass first-pass effects, thereby reducing the unit dose required to produce a desired therapeutic effect.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Leeuw RD, Klasser GD. Orofacial Pain: Guidelines for Assessment, Diagnosis, and Management. 5th ed. Hanover Park, IL: Quintessence Publishing Co, Inc. American Academy of Orofacial Pain 2018.  Back to cited text no. 1
    
2.
Sirintawat N, Sawang K, Chaiyasamut T, Wongsirichat N. Pain measurement in oral and maxillofacial surgery. J Dent Anesth Pain Med 2017;17:253-63.  Back to cited text no. 2
    
3.
Williamson A, Hoggart B. Pain: A review of three commonly used pain rating scales. J Clin Nurs 2005:798–804.  Back to cited text no. 3
    
4.
Dahiya M, Saha S, Shahiwala AF. A review on mouth dissolving films. Curr Drug Deliv 2009;6:469-76.  Back to cited text no. 4
    
5.
Vishal M, Anuj K, Naveen P, Kumud P, Sangram S. Formulation and evaluation of orodispersible tablets of lornoxicam. Int J Drug Dev Res 2011;3:281-85.  Back to cited text no. 5
    
6.
Misal NV, Chemate SZ. Formulation and evaluation of lornoxicam mouth dissolving tablet by using natural super disintegrates. Int J Pharm Sci Res 2019;10:1848-55.  Back to cited text no. 6
    
7.
Nidhi M, Patro MN, Kusumvalli S, Kusumdevi V. Development of transmucosal patch loaded with anesthetic and analgesic for dental procedures and in vivo evaluation. Int J Nanomedicine 2016;20:2901-20.  Back to cited text no. 7
    
8.
Annigeri RG, Jadhav M, Juturu T. Clinical evaluation of transmucosal mucoadhesive meloxicam patch in dental pain reduction: A preliminary study. Indian J Pain 2015:29:82-5.  Back to cited text no. 8
    
9.
Pattewar S, Pande V, Patil D, Sharma S. Fabrication and Characterization of self-micro emulsifying mouth dissolving film for effective delivery of piroxicam. Indian J Pharm Sci 2019:81:503-13.  Back to cited text no. 9
    
10.
Thriveni R, Rukhsar I, Ramesh DNSV, Patil SS, Byatnal A, Nair D. Development and clinical evaluation of transmucosal mucoadhesive patch of lornoxicam for the odontogenic pain management -A preliminary study. Natl J Integr Res Med 2019;11:12-6.  Back to cited text no. 10
    
11.
Tuzuner Oncul AM, Yazicioglu D, Alanoglu Z, Demiralp S, Ozturk A, Ucok C. Postoperative analgesia in impacted third molar surgery: The role of preoperative diclofenac sodium, paracetamol and lornoxicam. Med Princ Pract 2011;20:470-6.  Back to cited text no. 11
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2]



 

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