UNIVERSIDADE ESTADUAL PAULISTA
JÚLIO DE MESQUITA FILHO”
Instituto de Ciência e Tecnologia
Campus de São José dos Campos
ORIGINAL ARTICLE DOI: https://doi.org/10.4322/bds.2023.e3854
1
Braz Dent Sci 2023 July/Sept; 26 (3): e3854
Evaluating the efficacy of Etoricoxib in reducing post-operative pain
associated with minor oral surgery. A randomized clinical trial
Avaliação da eficácia do Etoricoxibe na redução da dor pós-operatória associada à cirurgia oral menor: ensaio clínico randomizado
Yusra Hameed AL-MUKHTAR1 , Zaid Hazim DELEME1 , Ahmed Salih KHUDHUR2
1 - Mosul University, College of Dentistry, Department of Oral and Maxillofacial Surgery. Mosul, Iraq.
2 - AlHadbaa University Collage, Department of Dentistry. Mosul, Iraq.
How to cite: Al-Mukhtar YH, Deleme ZH, Khudhur AS. Evaluating the efcacy of Etoricoxib in reducing post-operative pain associated
with minor oral surgery. A randomized clinical trial. Braz Dent Sci. 2023;26(3):e3854. https://doi.org/10.4322/bds.2023.e3854
ABSTRACT
Etoricoxib, a new cyclooxygenase-2-selective inhibitor has demonstrated a rapid onset analgesic effect for relieving
acute pain especially when prescribed as a pre-emptive medication. On these bases, this study may provide useful
information and guidance for clinicians working in the eld of oral surgery, as regards handling odontogenic
pain and postoperative pain precisely with cyclooxygenase-2 inhibitors. Objective: the study aimed to measure
the quantiable efcacy of Etoricoxib in reducing post-extraction pain in subjects undergoing minor oral surgical
intervention as compared to Naproxen (a traditional NSAID) which is commonly used to control postoperative pain.
Material and Methods: a 120 mg lm-coated tablet of Etoricoxib was given to each of the twenty patients representing
the study group, and a 500 mg tablet of Naproxen was given to each of the other twenty subjects representing the
positive control group. According to manufacturer instructions, the tablets were given to the subjects 30 minutes
pre-operatively (before dental extraction). Post-operative pain was assessed for each subject using eleven points
from zero to ten, visual analog scale. Results: showed no statistically signicant difference between Etoricoxib and
Naproxen in decreasing post-extraction odontogenic pain, suggesting that Etoricoxib is as efcient as Naproxen
in the control of discomfort with dental origin taking into consideration the patient’s status when prescribing the
medication. Conclusion: this study suggests that Etoricoxib can be handled as a pre-emptive medication to reduce
post-operative pain for subjects seeking traditional or surgical extraction of any of their teeth.
KEYWORDS
Etoricoxib; Pain; Oral surgery; Clinical Trial.
RESUMO
O Etoricoxibe, um novo inibidor seletivo da ciclooxigenase-2, demonstrou um efeito analgésico de início rápido para
aliviar a dor aguda, especialmente quando prescrito como medicação preventiva. Com base nesses fundamentos, este
estudo pode fornecer informações úteis e orientação para clínicos que trabalham no campo da cirurgia oral, no que diz
respeito ao manejo da dor odontogênica e da dor pós-operatória de forma precisa com inibidores da ciclooxigenase-2.
Objetivo: o estudo teve como objetivo medir a ecácia quanticável do Etoricoxibe na redução da dor pós-extração
em indivíduos submetidos a intervenção cirúrgica oral menor, comparado ao Naproxeno (AINE tradicional) que é
comumente usado para controlar a dor pós-operatória. Material e Métodos: um comprimido revestido com um
lme de 120 mg de Etoricoxibe foi administrado a cada um dos 20 pacientes representando o grupo de estudo,
e um comprimido de 500 mg de Naproxeno foi administrado a cada um dos outros vinte sujeitos representando o
grupo de controle positivo. De acordo com as instruções do fabricante, os comprimidos foram administrados aos
indivíduos 30 minutos antes da cirurgia (antes da extração dentária). A dor pós-operatória foi avaliada para cada
sujeito usando uma escala analógica visual de onze pontos, de zero a dez. Resultados: não mostraram diferença
estatisticamente signicativa entre o Etoricoxibe e o Naproxeno na diminuição da dor odontogênica pós-extração,
sugerindo que o Etoricoxibe é tão eciente quanto o Naproxeno no controle do desconforto de origem dentária,
levando em consideração o estado do paciente ao prescrever a medicação. Conclusão: este estudo sugere que o
Etoricoxibe pode ser administrado como medicação preventiva para reduzir a dor pós-operatória em indivíduos
que buscam extração dentária tradicional ou cirúrgica de qualquer um de seus dentes.
PALAVRAS-CHAVE
Etoricoxibe; Dor; Cirurgia oral; Ensaio Clínico.
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Braz Dent Sci 2023 July/Sept; 26 (3): e3854
Al-Mukhtar YH et al.
Evaluating the efficacy of Etoricoxib in reducing post-operative pain associated with minor oral surgery. A randomized clinical trial
Al-Mukhtar YH et al. Evaluating the efficacy of Etoricoxib in reducing post-operative
pain associated with minor oral surgery. A randomized clinical trial
INTRODUCTION
Pain has been dened as a negative subjective
emotional experience brought on by an unhealthy
stimulation of the sensory nerve endings that
may be linked to tissue damage. Dental pulp or
the periodontal ligament might be the source of
dental pain (a toothache). Dental pain is profound,
and somatic, and presents a variety of central
excitatory consequences and effects [1]. On the
other hand, Trigeminal nerve-innervated muscles
may develop trigger points, autonomic effects, and
spasm induction because of referred pain. Dental
pain is described as a dreary, oppressive sensation
that is occasionally throbbing, scorching, strong,
and transient pain. It might be confused with
other sources of pain because it is frequently hard
for the patient to recognize the exact damaged
tooth or site and may indicate that the pain is
coming from another tooth or location in one of
the jaws or on the face and neck [2]. When oral
tissue is injured, the inammatory response is
triggered, releasing a variety of inammatory and
pain mediators. Peripheral nociceptors are more
sensitive to and excited by mediating substances
such as prostaglandins and bradykinins, which
typically exhibit little natural action underneath
usual circumstances [1].
The non-steroidal anti-inammatory drugs
(NSAIDs), which include well-known nonselective
medicines like cyclooxygenase inhibitors-1 (COX1)
and a subclass of selective cyclooxygenase-2
(COX-2) inhibitors, are a diverse class of medications
with similar therapeutic effects and side effects.
Such medications are the preferred method for
treating mild to moderate pain, and the World
Health Organization recommends using them
on the following bases (WHO) [3]. Antipyretic,
anti-inammatory, and analgesic are the NSAIDs’
three primary benets; however, these medicines
can block the COX (1 or 2) enzyme to a greater
or lesser extent depending on their subclass,
characteristics, and structural chemistry variations.
Moreover, COX-2, which participates most in the
ability to reduce inammation and provide pain
relief, is of great importance [4,5]. NSAIDs are the
most often prescribed drugs for dental pain relief
after third molar extraction [6,7]. For the treatment
of osteoarthritis [8] and post-surgical dental pain,
selective cyclooxygenase-2 (COX-2) inhibitor
NSAIDs are just as clinically effective as nonselective
(COX-2) NSAIDs [9]. Mechanisms of dental pain:
Inammation is the primary cause of postoperative
dental pain, and prostaglandins produced by
cyclooxygenase are essential mediators of pain
by sensitizing free nerve endings to histamine,
bradykinin, adenosine triphosphate, and low
pH [10,11]. Glutamate, an excitation-inducing
amino acid, and substance P are two elements
released by free nerve endings’ central ends that
depolarize and produce their impulse [12,13].
When compared to other surgical procedures,
dental surgical trauma includes soft tissue and bone,
although the resulting defect surface is comparatively
tiny. Nonetheless, a signicant rise in prostaglandins
can be seen locally and systemically [14,15].
Further enhancing pain transmission is the
central nervous system’s (CNS) production of
Prostaglandins and other molecules that increase
or decrease pain sensitivity [10-12]. Because of
this, conventional NSAIDs prevent both the nal
production of prostaglandins (PGE1 and PGE2) and
cyclooxygenase isoforms (COX-1 and COX-2) [16].
COX-1 has been categorized as exclusively the
constitutive COX isoform in charge of producing
prostaglandin
mediators that participate in numerous
homeostatic
pathways such as gastrointestinal
cytoprotection (i.e., prostaglandin E2) and platelet
aggregation (i.e., thromboxane A2); COX-2 has
also been categorized as solely the upregulated
isoform responsible for making prostaglandin
compounds elaborate in pain and inammation
(i.e., PGE2) [17]. A once-daily dose of 120 mg
film coated-tablets, Etoricoxib, a non-steroidal
anti-inammatory drug, acts by obstructing the
end-products of cyclo-oxygenase-2 (COX-2)
enzymes such as prostaglandins which cause
pain and inflammation resulting in reduced
quantities of prostaglandins produced, thereby
alleviating pain and inflammation [18].
Naproxen (a well-known NSAID) is used for
adults’ painful conditions such as ankylosing
spondylitis, osteoarthritis, and rheumatoid
arthritis. The standard dosage is 500 mg to 1g per
day in two divided doses at 12-hour intervals [8].
NSAIDs are contraindicated in patients who have
formerly shown allergic responses “e.g. asthma,
rhinitis, angioedema or urticaria in reaction
to Ibuprofen, Aspirin, or other non-steroidal
anti-inammatory drugs”. [10]
Aim of the study
This clinical trial aimed to evaluate whether
a pre-emptive high dosage of Etoricoxib can
decrease postsurgical pain in subjects undergoing
minor oral surgery.
3
Braz Dent Sci 2023 July/Sept; 26 (3): e3854
Al-Mukhtar YH et al.
Evaluating the efficacy of Etoricoxib in reducing post-operative pain associated with minor oral surgery. A randomized clinical trial
Al-Mukhtar YH et al. Evaluating the efficacy of Etoricoxib in reducing post-operative
pain associated with minor oral surgery. A randomized clinical trial
The objective of the study
The aim of this study was fullled by evaluating
the efcacy of Etoricoxib in reducing post-extraction
pain in subjects undergoing minor oral surgical
intervention as compared to Naproxen which is
commonly used to control postoperative pain.
Approval of the study
The study was registered by the Oral and
Maxillofacial Surgery Department/College of
Dentistry Scientic Committee / Mosul University
on 14 September 2022. Before starting the study,
the Research Ethics Committee at the College of
Dentistry / Mosul University (reference number
UoM.Dent/H.41/22 on 26 December 2022)
granted ethical approval for its protocol.
MATERIALS AND METHODS
This study was designed as a controlled,
parallel, clinical study conducted in a double-blind
fashion. It was carried out from the 2nd of October
2022 until the 10th of November 2022. The study
subjects were recruited from the patients attending
the Oral Surgery Clinic at the College of Dentistry,
the Department of Oral and Maxillofacial Surgery,
and Mosul University. The patients were informed
of the study protocol and potential risks before
participating. Upon acceptance, each patient signed
a written consent form to participate in the study.
Inclusion and exclusion criteria
1. Age range 18-70 years old males and females.
2. Healthy subjects i.e., with no systemic diseases
or conditions or physiologic status such as
pregnancy for females that may contraindicate
the administration of any of the study’s
medications.
3. No allergy to any of the selected medications.
4. Taking any analgesic or anti-inammatory
drug before their participation for at least
1 hour is forbidden.
5. Fully aware patients, i.e., those who can
communicate and give full information
about themselves and can give consent.
Study groups
Based on the selection criteria, forty healthy
subjects arranged to go through surgical intervention
for one of their teeth were recruited in the research.
The 40 subjects were distributed equally into two
treatment groups: the Etoricoxib group and the
Naproxen group.
Medications
Two NSAID medications were used including
1. Etoricoxib 120 mg lm-coated tablets from
United Pharmaceutical Manufacturing
Limited Company, Amman/ Jordan.
2. Naproxen 500 mg tablets from Wockhardt
UK Ltd. Company.
Protocol and measures
To avoid bias and to assure the double-
blinded path of the study, a qualied oral surgeon
was assigned to provide the study’s medications
to the subjects. On the other hand, neither the
researchers nor the subjects knew the medication
type given to each subject until the time of the
results analysis. Accordingly, either a 120 mg
Etoricoxib tablet or a 500 mg Naproxen tablet
(sealed in a similar premade package), was given
to each patient 30 minutes pre-operatively.
An eleven-point (0–10) visual analog scale
(VAS) was used for pain assessment measures. It is
commonly employed to evaluate the frequency or
severity of various symptoms in epidemiological
and clinical studies [19]. For instance, the degree
of discomfort that a subject experiences can be
anywhere along a continuum, from none to
extremely high levels. The categories of none,
mild, moderate, and severe would imply that this
spectrum is divided into discontinuous jumps,
but the subject views it as a continuous range.
The VAS was developed to capture this notion
of an underlying continuity [20]. It was utilized
to calculate pain “0, no pain; 1-3, mild pain;
4-6, moderate pain; 7-9, severe pain; and 10,
miserable pain”.
Statistical analysis
Data were analyzed using SPSS software
Statistics for Windows, version 18, Chicago: SPSS
Inc. USA. As the study data were not normally
distributed (pain VAS measures are always
nite and subjective), median and interquartile
range (IQR) were used to present the results of
the study. Non-parametric statistical tests were
used for comparisons between and within the
two study groups. Mann-Whitney test was used
for the comparison of VAS measures between
4
Braz Dent Sci 2023 July/Sept; 26 (3): e3854
Al-Mukhtar YH et al.
Evaluating the efficacy of Etoricoxib in reducing post-operative pain associated with minor oral surgery. A randomized clinical trial
Al-Mukhtar YH et al. Evaluating the efficacy of Etoricoxib in reducing post-operative
pain associated with minor oral surgery. A randomized clinical trial
Etoricoxib group and Naproxen group, as they
were non-related groups. Wilcoxon Signed Rank
test was used for the comparison of VAS measures
between males and females within the same
group. Differences were considered statistically
signicant only if the p-value was <0.05.
RESULTS
Forty subjects were involved in the study
divided into two treatment groups Etoricoxib 120 mg
(n = 20) and Naproxen sodium 500 mg (n = 20). Both
groups were equal for the starting point pain intensity,
period of surgery, and number of teeth extracted.
Data for both groups included number, gender, age
range, and pain scores with median and IQR for both
treatment group, as shown in Tables I and II.
Statistical analysis showed that there were no
statistically signicant differences (p-value > 0.05)
between the two treatment groups and within
each group (males versus females), as shown in
Table III and Table IV.
DISCUSSION
Following dental surgery, dental patients
may have discomfort and pain; hence, analgesics
and/or anti-inflammatory medications are
frequently administered to alleviate moderate
or severe pain and to prevent the spread of pain,
especially for vulnerable individuals, or those
who require analgesics [21]. NSAIDs primarily
function by blocking the cyclooxygenase enzyme
(COX) which is necessary for the production
of pain and inflammatory mediators such as
prostaglandins, thromboxane, and prostacyclin by
converting arachidonic acid into prostaglandins,
and these in turn to the other mediators [22].
Nonsteroidal anti-inammatory medications have
been utilized a lot to lessen problems after third
molar surgery [23,24], and are frequently used
to treat acute inammatory pain disorders as well
as persistent neuropathic pain [25,26]. In their
clinical trial, Malmstrom et al. 2004 demonstrated
that the higher painkilling outcome of Etoricoxib
and Naproxen along with Acetaminophen/Codeine
was established by the percentage of patients
suffering no or slight pain after receiving the
required dose of the medication. Most of the
patients on Etoricoxib or Naproxen experienced
Table I - Descriptive Statistics of Etoricoxib group
Naproxen 500 mg tablets
N Male Female Age Range per year Median
Pain Score
Interquartile
Range
20 14 6
21-65 0 0
31-65 0 0
21-56 0 0
Table II - Descriptive Statistics of Naproxen group
Etoricoxib 120 mg tablets
N Male Female Age Range per year Median
Pain Score
Interquartile
Range
20
23-68 0 0
12 35-68 0 0
8 23-57 0 3.25
Table III - Pain comparisons between the two study groups
Comparisons p-value*
Etoricoxib 20 Patients versus Naproxen 20 Patients 0.144
Etoricoxib 12 Males versus 14 Naproxen Males 0.911
Etoricoxib 8 Females versus 6 Naproxen Females 0.106
*Mann-Whitney Test, p-value>0.05 (Non-significant)
Table IV - Pain comparisons within the two study groups
Comparisons p-value*
Etoricoxib 12 Males vs Etoricoxib 8 Females 0.109
Naproxen 14 Males vs Naproxen 6 Females 1
*Wilcoxon Signed Rank Test, p-value >0.05 (Non-significant)
5
Braz Dent Sci 2023 July/Sept; 26 (3): e3854
Al-Mukhtar YH et al.
Evaluating the efficacy of Etoricoxib in reducing post-operative pain associated with minor oral surgery. A randomized clinical trial
Al-Mukhtar YH et al. Evaluating the efficacy of Etoricoxib in reducing post-operative
pain associated with minor oral surgery. A randomized clinical trial
no or slight pain, as compared to less than half
of the patients on Acetaminophen/Codeine [27].
The alimentary harmfulness linked with NSAIDs
is believed to be initiated by the simultaneous
inhibition of COX-1 [28], an undesirable side
effect of NSAIDs [29], which falls in favor
of Etoricoxib. Regarding results, showed the
efficacy of etoricoxib was better than that of
placebo and similar to that of naproxen; both
etoricoxib and naproxen were also generally well
tolerated [30], so inadequate postoperative pain
management resulted in a signicant deterioration
in the quality of life of the patients after teeth
removal [31]. Etoricoxib reached the cerebrospinal
uid (CSF) and the surgical site in an effective
concentration and reduced the production of
PGE2 at the presumed site of action [32]. This
process resulted in complete blockade of PGE2
production in the surgical wound of extraction
and CSF. This phenomenon can lead to pain relief
and reduce demands for post-operative analgesics.
A single 120 mg dose of Etoricoxib, a new COX-2
targeting agent, offered superior analgesic effect
compared with placebo. Etoricoxib 120 mg also
offered superior analgesic effect to 2 tablets of
Acetaminophen/Codeine (total dose 600/60 mg),
an opioid-containing analgesic, while the analgesic
effect of etoricoxib 120 mg was similar to that of
naproxen sodium 550 mg, a non-selective NSAID.
Which is an accepted, sensitive, and validated
model for assessing acute pain of moderate
to severe intensity [21]. The similar efficacy
demonstrated between Etoricoxib and Naproxen
in this study. This is likely explained by the fact
that the biological variation of the selected cases
in our study.
CONCLUSION
In a similar manner to NSAIDs, this study
suggests that Etoricoxib can be used as a
pre-emptive medication to reduce post-operative
pain for patients undergoing extraction or
surgical extraction of any of their teeth, avoiding
the undesirable side effects of other NSAIDs drugs
such as Naproxen.
Acknowledgments
The authors are grateful to the College of
Dentistry at the University of Mosul for their
content contributions and their critical review
of the manuscript and their support during the
development and writing of this manuscript.
Author’s Contributions
YHAM: The idea of the research and writing
the introduction and materials and methods.
ZHD: Surgical part of the study and results with
statistic and discussion references writing. ASK:
Aid in surgical part and plagiarism paraphrasing
and discussion writing.
Conict of Interest
The authors have no proprietary, nancial,
or other personal interest of any nature or kind
in any product, service, and/or company that is
presented in this article.
Funding
This research did not receive any specic
grant from funding agencies in the public,
commercial, or not-for-prot sectors.
Regulatory Statement
This study was conducted following all the
provisions of the local human subject’s oversight
committee guidelines and policies of the Oral
and Maxillofacial Surgery Department/College of
Dentistry Scientic Committee / Mosul University
on 14 September 2022. The Research Ethics
Committee. The approval code for this study is
UoM.Dent/H.41/22 on 26 December 2022.
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7
Braz Dent Sci 2023 July/Sept; 26 (3): e3854
Al-Mukhtar YH et al.
Evaluating the efficacy of Etoricoxib in reducing post-operative pain associated with minor oral surgery. A randomized clinical trial
Al-Mukhtar YH et al. Evaluating the efficacy of Etoricoxib in reducing post-operative
pain associated with minor oral surgery. A randomized clinical trial
Zaid Hazim Deleme
(Corresponding address)
Mosul University, College of Dentistry, Department of Oral and Maxillofacial
Surgery, Mosul, Iraq.
Email: ziaddeleme@uomosul.edu.iq
Date submitted: 2023 Apr 06
Accept submission: 2023 Aug 18