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

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.

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.

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

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

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)

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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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

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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

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