Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"



Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018




Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
Knowledge is treasure of a wise man. The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help ones reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journalsNo manuscriptsNo authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

Original article / research
Year : 2010 | Month : June | Volume : 4 | Issue : 3 | Page : 2398 - 2405

A Comparative Study Of Oral Analgesics: Etoricoxib With Tramadol In Acute Postoperative Pain: A Randomised Double Blind Study

KUMARAVELU P, KALIAPPAN V, VISWANATHAN G, DAVID D C, VENKATESAN H Correspondence Address :
punagai.pharma@gmail.com

Abstract

Background: Etoricoxib is known to be a selective inhibitor of the cox-2 enzyme. It is an effective analgesic, associated with a reduced risk of bleeding due to platelet dysfunction, gastrointestinal bleeds and ulcers. Studies on etoricoxib in the dental extraction pain model have proved the superior efficacy of etoricoxib with fewer adverse effects as compared to oxycodone/acetaminophen.
Aims: The aim of this study was to compare the efficacy and tolerability of oral etoricoxib 120mg with oral tramadol 100 mg in postoperative pain. This comparison will help to determine the rapidity and sustained efficacy of these agents in pain relief and the possible side effects attributable to the medications.
Settings and Design: The study was conducted among 60 patients with one or more impacted third molar teeth, posted for extraction at the oral surgery department of the Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem, Tamil Nadu. Patients selected for the study were randomized by a computer generated list using random allocation software and were given a sequentially-numbered sealed opaque envelope containing the study drugs by the blinded investigator.
Methods and Material: Pain assessment was done by assessing the following: mean pain scores using a 10 point VAS scale, investigator assessment of ancillary clinical outcomes, inflammation, opening of the mouth, global assessment of study medications and the incidence of adverse effects.
Statistical Analysis used: The statistical analysis was done by using the paired preference test. Unpaired t test was used to compare the mean VAS score values from day 0 to day 5.
Results and Conclusions: The frequency of the inflamed condition at day 0 to the uninflammed condition at day 5 was 86.67% and 70% respectively for etoricoxib and tramadol. Statistically, etoricoxib was preferred to tramadol by a T score of 0.667 (50% confidence). The frequency of lack of pain was found to be predominant in etoricoxib as compared to tramadol (93.34% versus 60%). Preferential analysis showed a clear preference for etoricoxib, with a T score of 1.219, significant at a 77% confidence level. Etoricoxib had a superior effect over tramadol in terms of anti-inflammatory and analgesic properties. Patients receiving cox-2 inhibitors had a lower incidence of gastritis and drowsiness as compared to patients receiving tramadol.

Keywords

etoricoxib, anti-inflammatory and analgesic, dental pain, tramadol, etoricoxib efficacy

Introduction
Acute pain serves as an important biological function as it warns about the extent of injury or its potential for worsening. It is a rapid response to a noxious stimulus that does not produce long term sequela (1). On the other hand, it can have adverse psychological and emotional effects. Therefore, attention is being focused on the aggressive prevention and treatment of acute pain to reduce complications and progression to chronic pain states.

Dental pain is a painful sensation which can be evoked by a specific dental treatment. Removal of the third molar teeth is widely used as an experimental pain model in pharmacological studies on the effect of analgesic drugs (2).

The post operative period is characterised by pain, trismus and inflammation frequently (3) 3 It can cause significant suffering, anxiety, fear, anger and depression. An ideal drug administered after the surgical removal of impacted third molar should alleviate pain and associated symptoms, facilitate healing and cause no undesirable side effects (4).

Pain is assessed using the Visual Analog Scale (VAS) and four and five point categorical scales to assess the efficacy variables (5),(6). The Visual Analog Scale is an easy method that is simple to understand and interpret by the population that is under study. It is a ten point scale with increasing severity. Pain parameters are graded numerically and pictorially. They are easy, inexpensive and are frequently used.

The selection of analgesics is based on previous studies on safety and tolerability. Cox-2 NSAIDs which selectively inhibit the cox-2 isoenzyme were developed to limit the NSAID adverse effects. Etoricoxib is known to be a selective inhibitor of the cox-2 enzyme. It is an effective analgesic which is associated with a reduced risk of bleeding due to platelet dysfunction, gastrointestinal bleeds and ulcers (7), (8).

Etoricoxib has been tried in the management of several conditions including pain, osteoarthritis, and rheumatoid arthritis. It was noted that Etoricoxib had a similar efficacy when compared with the traditional NSAIDs (including naproxen, diclofenac and ibuprofen) in these conditions. Etoricoxib was chosen since it was found to have equipotent efficacy to the traditional NSAIDs and opioids and shows a prolonged action with lesser adverse effects like gastric irritation (9). (10).

Reviews of published studies have noted that at least 50% pain relief was reported by 64% users of etoricoxib 120 mg. Also, significantly fewer participants opted for rescue medication when on etoricoxib 120 mg than those taking placebo. The 120 mg dose of etoricoxib was reported to be as effective as, or better than other commonly used analgesics (11).

Studies on etoricoxib in the dental extraction pain model have proved the superior efficacy of etoricoxib with fewer adverse effects as compared to oxycodone/acetaminophen (12).

Tramadol hydrochloride is an oral narcotic analgesic whose effects are brought about through its influence on the central nervous system. It relieves moderate to severe pain by combining synergistically weak opioid and monoaminogerically mediated anti-nociceptive mechanisms (13).

Tramadol, a nonscheduled drug is marketed as an effective and safe analgesic for moderate to moderately severe pain. McQuay and Moor reviewed 18 studies which demonstrated that all doses of tramadol were superior to placebo in relieving postsurgical and dental pain and showed a dose-response effect (14). Studies have claimed that it has a low potential for abuse and psychological dependence and also as an effective analgesic that is well tolerated by both the adult and the paediatric patient population (15),(16).

Adverse effects such as nausea, vomiting and dizziness may occur with the use of tramadol. It should be used with caution in patients with a history of seizure disorder. Tramadol is contraindicated in patients with a tendency of opioid abuse or dependence (17).

Comparison of the analgesic efficacy of etoricoxib with tramadol is not studied until now. The aim of this study was to compare the efficacy and tolerability of oral etoricoxib 120mg with oral tramadol 100 mg in postoperative pain. The comparison of the analgesic drugs in this study aimed to determine the rapidity and sustained efficacy of these agents in pain relief and the possible side effects attributable to the medications; the efficacy variables considered were pain intensity and the physician assessment of pain and inflammation (18).

Material and Methods

This was a randomized, double blind parallel group comparator – controlled trial, conducted at the oral surgery department of Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem, Tamil Nadu, between August 2006 and June 2007.

Patients posted for the surgical extraction of one or more impacted third molar tooth, partially or fully impacted or in the germinal phase, were included in the study. The study population included men and women with ages ranging from 18 – 60 years, who were eligible for standard intervention and specifically anterior discharge cutting, followed by suture of the cut. It was also made sure that the subjects included had no acute ongoing inflammation of the oral cavity at the time of surgery. Further, good general health and patient self-assessment, with particular emphasis on the reports of past or current gastric or duodenal ulcers and anaemia were also considered in the inclusion criteria.

Patients above 60 years, children below 18 years and women who were pregnant or lactating, were not included in the study. Patients with a history of conditions such as: infective caries, peptic ulcer, bronchospasm, angio-oedema, urticaria, renal and hepatic disease, seizures, recent angina, hypertension, myocardial infarction, fluid retention and oedema were excluded from the study. Further, smokers/alcoholics and those on steroids or other analgesics were also excluded.

The study was conducted among 60 patients with one or more impacted third molar teeth, posted for extraction at the oral surgery department of the study centre.

The Institutional Ethics Committee approved the study protocol and the informed consent form. All the eligible patients were informed about the purpose and requirements of the study, details of the drugs, efficacy and safety points. Patients were informed about their freedom to withdraw from the study without giving any reason at any given time and they were informed that while doing so, they would not be denied the option of continuing quality medical care in the same institute. Written informed consent was obtained in the local language – Tamil from each patient. Case record forms were prepared for each of the patients and were kept with the investigator. Drugs were given free of cost to the patients. Patients were advised to take the medication as prescribed and to come for a follow up. They were advised to report any adverse event to the investigator immediately over phone.

Details of the patient’s demographical profiles, medical history, dental and allergic history, concomitant medication, physical examination and dental examination and the type of extraction procedure were recorded. Patients who were selected for the study were randomized by a computer generated list using random allocation software and were given a sequentially-numbered sealed opaque envelope containing the study drugs by the blinded investigator.

Local anaesthesia was administered during all interventions; intravenous sedation was not used on the patients in the study. After the extractions were completed, the patients were supplied with a neatly packaged course of their study analgesics. Patients were allowed to use rescue medication if the study drug was not effective in controlling the pain.

The study drugs used were T.Etoricoxib 120mg OD and T.Tramadol 100mg OD. All the drugs were prescribed for a period of five days and the first dose was given one hour after completion of the surgery and was continued until suture removal on day 5. All patients received postoperative prophylactic antibiotics Cap.Amoxicillin (1g every 12h for 5 days) and T. Metronidazole 400mg TID.

Pain scores using Visual Analog Scales were evaluated at 1 hour after surgery and after 8 hrs at the time of discharge by a blinded observer. All patients were provided VAS sheets in which they were instructed to record pain intensity over 5 consecutive days, starting with the day of surgery. These VAS scales were collected on the 5th day after surgery, when the sutures were removed. The investigator evaluated the outcome of surgery in each patient by using a proforma data collection form that included questions about the appearance of the tissues and ease / pain associated with the opening of the mouth.

All data thus accrued were incorporated into a database and were used by a statistician for analysis.
Pain assessment was done by:
i) Mean pain scores using a 10 point VAS scale. (0-indicates no pain, 1-mild pain, 2- discomforting pain, 3- distressing pain, 4-intense pain, 5-excruciating pain)
ii) Investigator assessment of ancillary clinical outcomes:
a. Inflammation (A – No inflammation, B- Mild inflammation, C- Severe inflammation) and
b. Opening of the mouth (A – Restriction with pain, B – Not restricted with pain, C- Not restricted without pain)
iii) Global assessment of study medications: (1-Poor, 2-Fair, 3-Good, 4-Excellent)
iv) Incidence of adverse effects

Statistical Analysis
The statistical analysis was done by using the paired preference test. A paired preference test determines whether there is a statistically significant preference between two products for a given population of respondents. Paired preference testing can address the overall preference or preference for a specified sensory attribute. Unpaired t test was used to compare the mean VAS score values from day 0 to day 5. P values less than 0.05 were considered to be significant.

Results

A total of 100 eligible patients were screened and gave their informed consent for participation in this trial. However, 15 of these patients did not meet the inclusion criteria. Therefore, 85 patients were eventually included. Among these 85 patients, 40 were randomized to the Tramadol group and 45 patients were assigned to the Etoricoxib group.

8 patients did not turn up for the follow-up. 5 patients did not return the case report form and 2 patients violated the study protocol by taking the rescue drug less than 2 hours after study drug intake in all the treatment groups. These patients were excluded from the treatment effect analysis. Finally, 30 patients in each group completed the study successfully on day 5.

(Table/Fig 1) shows the demographic profiles and clinical features of these 60 patients. All 60 patients underwent upper and lower impacted molar tooth extraction by our technique. The baseline characteristics among the treatment groups were statistically similar with respect to age and sex and baseline pain intensity.


Physicians’ Assessment
The reduction of inflammation caused by etoricoxib and tramadol were compared in this study. The frequency of the inflamed condition at day 0 to the uninflammed condition at day 5 was 86.67% and 70% respectively for etoricoxib and tramadol. The statistical analysis showed a preference for etoricoxib, with a T-score of 0.667, significant at a 50% confidence level. The complete comparison is given in (Table/Fig 2).

Pain On Opening Mouth
Four sets of observations were seen in the patients studied. However, only three types of observations were seen in the etoricoxib group. No restriction and no pain from a restricted opening was a predominant frequency in both the groups, implying good analgesic effects by the drugs (66.67% versus 53.33% respectively for etoricoxib and tramadol). Therefore, this effect was used as a parameter for the comparison in the preference test. Statistically, etoricoxib was preferred to tramadol by a T score of 0.667, which was significant at a 50% confidence level. The complete analysis of the study is depicted in (Table/Fig 3).


Patient’s Assessment
Diminished/reduced pain was assessed by patients themselves on day 0 and day 5. The frequency of lack of pain was found to be predominant in the etoricoxib group as compared to the tramadol group (93.34% versus 60%). Etoricoxib was statistically preferred over tramadol due to the comparative analysis of the T score of 1.475, which was significant at an 85% confidence level.

The unpaired t test demonstrated clear significance rates with the use of etoricoxib. The mean VAS scores were almost equal at 0 hours while significant differences were noted in the subsequent recordings (Table/Fig 4). A significant difference was noted at 8 hours (p=0.0423), while the difference was extremely significant on days 2 and 4 (p <0.0001). Further, the difference was also highly significant on days 3 and 5 (p=0.0423 and 0.0043 respectively).

Global Assessment
Global assessments were carried out to categorize the treatments as poor, fair, good, and excellent. The Etoricoxib treatment showed no patients with poor clinical outcome, while six patients in the tramadol group were categorized as poor. Etoricoxib was assessed as excellent in 26.67% patients. Both treatments had high frequency of ‘good’ as categorization (66.67 versus 43.33 for etoricoxib and tramadol respectively). Preferential analysis of this data showed a clear preference for etoricoxib, with a T score of 1.219, significant at a 77% confidence level. The complete global analysis of the treatments is given in (Table/Fig 5).


Side Effects
The total number of side effects reported were 33, among which 27 were reported in the tramadol group. The incidence of the side effects such as dizziness or sedation was reported in a considerably higher number of people (19 vs 2) who took tramadol. Nausea and vomiting were comparatively higher with tramadol treatment than with the treatment with etoricoxib in appropriate doses. No serious adverse events occurred (Table/Fig 6).

Discussion

Mean pain scores following surgical extraction of impacted third molars are comparable to the maximum pain scores from a number of painful conditions like back pain and cancer. Thus, the present study has the power to predict the analgesic efficacy of orally administered Etoricoxib and Tramadol in pain states of moderate to severe intensity, as in more extensive surgical procedures.

This study reconfirms the analgesic efficacy of the two drugs used in this study, with significant reduction in the pain intensity during the postoperative period following extraction of the impacted third molars.

Ancillary clinical endpoints such as inflammation, swelling and jaw movement improved satisfactorily among the two drugs. T.Etoricoxib had significant anti-inflammatory efficacy and beneficial effect on local postoperative trauma than tramadol. The reduction of inflammation caused by etoricoxib and tramadol on day 5 was considerably higher (86.67% and 70% respectively). The presence of mild inflammation even on day 5 on the other hand, was reported by only about 13% of the subjects treated with etoricoxib, while 30% of those treated with tramadol showed the presence of mild inflammation on day 5.

A higher percentage of subjects who took etoricoxib (30%) reported both reduction in pain and unrestricted mouth opening as compared to those who took tramadol (23%). The results of the unpaired t test revealed the difference in effects of etoricoxib over tramadol. The difference was extremely significant on days 2 and 4, while a significant difference existed on all other days.

A prolonged analgesic effect was observed with the treatment of etoricoxib. The patient assessment scores denoted statistically significant difference in pain reduction with respect to etoricoxib (93.34% reported lack of pain) versus tramadol (60% had no pain) at the end of 5 days.

Preferential analysis of the global assessment data denoted a clear preference for etoricoxib (T score of 1.219 significant at 77% confidence level) over tramadol.

Safety assessment showed that the two drugs used in the study were generally well tolerated. Gastrointestinal side effects like vomiting and nausea were greater in the Tramadol group as compared to the cox-2 inhibitor, Etoricoxib.

Pharmacodynamically, the selective cox-2 inhibitors are as effective as the older generation of non selective NSAIDs like Ibuprofen and diclofenac sodium. Cox-2 inhibitors have a longer duration of action and a rapid onset of action as compared to the various 1st generation NSAIDs (19). Etoricoxib has been authorized in all European Union member states and 60 other countries around the world for a number of years and its benefits have outweighed the risks for the treatment of conditions like Rheumatoid arthritis and Ankylosing spondylitis (20).

However, the long term use of cox-2 inhibitors has been found to increase the cardiovascular and cerebrovascular adverse effects. The adverse events were attributed to the action of these drugs which affect the balance between the prothrombotic and antithrombotic processes. Cox-2 inhibitors decrease PGI2 production which has antithrombotic properties; so these agents are found to increase the likelihood of thrombotic events and hypertension. In addition, Cox-2 inhibitors have antiatherogenic effects, as they inhibit inflammation. They do not have any significant effect on platelet function as cox-1 inhibitors (21).

Tramadol being a centrally acting narcotic with a significant analgesic effect as compared to the NSAIDs can be preferred in cases of hypersensitive reactions to NSAIDs. It is also preferable in patients with severe anxiety associated with surgery, since it produces significant sedation. Further studies are needed to find out the analgesic efficacy and tolerability of Tramadol in doses above 100mg in postoperative pain and to study the combined effect of tramadol with newer cox- inhibitors like Etoricoxib in pain. Etoricoxib might prove to be a superior analgesic than other drugs in the market.

Conclusion

In this clinical study, the drugs under evaluation, Tramadol 100mg OD and Etoricoxib 120mg OD were almost equivalent in efficacy and tolerance. Etoricoxib however, had a superior effect over tramadol in terms of anti-inflammatory and analgesic properties. The patients preferred etoricoxib to a greater extent than tramadol. Patients receiving cox-2 inhibitors had lower incidence of gastritis and drowsiness as compared to patients receiving tramadol.


Key Message

• Etoricoxib had a superior effect over tramadol in terms of anti-inflammatory and analgesic properties.
• The efficacy and tolerance of etoricoxib 120mg OD was almost equivalent to that of tramadol 100mg OD.
• Subjects in the study preferred etoricoxib to a greater extent than tramadol.
• Cox-2 inhibitors have a lower incidence of gastritis and drowsiness as compared to tramadol.
• Newer Cox- inhibitors like etoricoxib might prove to be superior analgesics than other drugs in the market.

Acknowledgement

Declarations
No funding for the paper
No conflicts of interest

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