The Value of (Chlorzoxazone 250 mg + Paracetamol 300 mg) in Relieving Postoperative Trismus and Pain after Surgical Removal of Impacted Lower ...
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Waseem Kh. Mahmood, Saif S. Ali Al-Jewari & Zaid A. Muhammad Volume 8, Issue 1, 2021
The Value of (Chlorzoxazone 250 mg + Paracetamol
300 mg) in Relieving Postoperative Trismus and Pain
after Surgical Removal of Impacted Lower Wisdom
Teeth (Clinical Study)
1
Waseem Khalid Mahmood, MSc., 2Saif Saad Ali Al-Jewari, FIBMS, and 3Zaid
Abdulazeez Muhammad, MSc.
1, 2, 3
Department of Oral and Maxillofacial Surgery, College of Dentistry,
University of Mosul, Iraq.
Corresponding author: Zaid Abdulazeez Muhammad
Email address: Zaidabdulaziz@uomosul.edu.iq
Received March 28, 2021.
Accepted for publication on May 25, 2021.
Published June 06, 2021.
Abstract
Background Reduction of postoperative drawbacks related to extraction of lower wis-
dom teeth is an important goal in oral surgery. Chlorzoxazone, a centrally acting mus-
cle relaxant, could be use following surgical removal of lower wisdom teeth, to replace
other alternative medications such as steroids, non-steriodal anti-inflammatory drugs
and diazepam particularly when the access to these medications is limited or contrain-
dicated. Objectives this study aims to evaluate a combined therapy (Chlorzoxazone
250 mg + Paracetamol 300 mg), in relieving of postoperative trismus and pain after
surgical removal of lower wisdom teeth compared with paracetamol 500 mg.
Materials and Methods thirty healthy patients participated in this prospective clini-
cal study. They were divided into two groups; the test group received the combined
therapy (Chlorzoxazone 250 mg + Paracetamol 300 mg) and antibiotic while the control
group received just paracetamol 500 mg and antibiotics as postoperative medications.
Postoperatively, one independent investigator performed clinical examinations.
Results the combined therapy (Chlorzoxazone 250 mg + Paracetamol 300 mg) pre-
sented a good postoperative effect to relief the trismus related to the operation
Conclusions this could justify the use of this combination therapy as an alternative to
steroidal and non-steroidal anti-inflammatory agents particularly when these medica-
tions contraindicated in certain medically compromised patients.
Keywords: Impaction; chlorzoxazone trismus; pain.38
Waseem Kh. Mahmood, Saif S. Ali Al-Jewari & Zaid A. Muhammad Volume 8, Issue 1, 2021
Introduction samples indicated a rapid absorption and
To improve the treatment outcome and to rapid elimination of Chlorzoxazone. Aver-
reduce the postoperative visits which in- age values of the elimination half-life and
crease patient satisfaction, reduction of plasma clearance were 1.12 +/- 0.48 hr
complications resulted following extrac- and 148.0 +/- 39.9 ml/min, respectively
tion of lower wisdom teeth is the key to (Desiraju et al, 1983). The purpose of this
achieve these goals. These complications study was to evaluate the clinical use of
appear in form of pain, swelling, trismus, combined therapy (Chlorzoxazone 250 mg
and alveolar osteitis. Different therapies + Paracetamol 300 mg) in relieving post-
have been assessed and published in the operative trismus after surgical removal
literature to control postoperative draw- of wisdom teeth as it can be considered
backs related to the extraction of lower as a replacement of other medications fol-
wisdom teeth. These therapies are Anal- lowing long oral surgery procedures like
gesics (Bailey et al, 2014), Corticosteroid NSAID, Steroids and other muscle relax-
(Alexander et al, 2000), Antibiotics (Ren et ants such as diazepam particularly when
al, 2007). Antibacterial mouthwashes such these medications not recommended for
as Chlorhexidine mouthwash (Caso et al, certain medically compromised cases ex-
2005), topical gels of antimicrobial agents cluding patients with liver disease.
(Hita-Iglesias et al, 2008), Irrigation (Daly
et al, 2012; Ghaeminia et al, 2016), and Materials and Methods
cryotherapy (Ibikunle et al, 2016). Cho et Study Design
al 2017 concluded in their review of mul- This clinical study was approved and regis-
tiple evidence-based studies that there is tered by the ethics and scientific commit-
strong evidence for using paracetamol and tee at the University of Mosul / College of
ibuprofen in the management of postoper- Dentistry, Department of Oral and Maxil-
ative pain. Corticosteroids reduce swelling lofacial surgery. The protocol followed the
and trismus after surgery but they should guidelines in the Declaration of Helsinki
only be used in selected cases. Chlorhex- and all participants were informed about
idine mouthwash and gels are proven to be the details of the procedure in a written
efficient in reducing alveolar osteitis. There informed consent which was signed by all
is no clear evidence concerning the use patients before recruitment in this study.
of cryotherapy after third molar removal. A specific selection criterion was applied to
The impact of using a muscle relaxant to avoid unwanted results. Inclusion criteria
reduce pain, swelling, and trismus follow- included Male and females aged 18 years
ing surgical removal of lower wisdom teeth old or above who read and signed the writ-
has not been studied well. Chlorzoxazone ten informed consent for their participa-
is a centrally acting muscle relaxant used tion in the study, partial bony impacted
to treat muscle spasms. It is commonly mandibular third molars with Class II or III
used after lower spine surgery (Nielsen et and position A, B, or C, according to Pell
al, 2016). The most concerning side effects and Gregory classification on a radiograph.
of this medication are liver toxicity particu- The patient indicated for lower wisdom
larly when Chlorzoxazone combined with tooth extraction without local or/and sys-
paracetamol as the latter has the same temic limitations. The geographic proxim-
side effect but this drawback might hap- ity of living should allow adequate follow-
pen only when consuming these medica- up. On the other hand, exclusion criteria
tions for chronic use for several months involved Patients with liver disease, dental
(Powers et al,1986). Analysis of plasma infection such as pericoronitis, medically39
Waseem Kh. Mahmood, Saif S. Ali Al-Jewari & Zaid A. Muhammad Volume 8, Issue 1, 2021
compromised patients, and history of al- Visual Analogue Scale measured from (0-
lergy or hypersensitivity to the drugs used 10) cm to assess pain severity after the
in this trial, recent use of anti-inflammato- operation and the response to analgesics
ry drugs or muscle relaxants, chronic use (Gould et al, 2001). The time of operation
of any medication (any corticosteroids or from the administration of local anesthe-
NSAIDs), pregnant or lactating females. sia to the end of suturing was measured
Regarding sample randomization, thirty for the general assessment of the cases.
patients were recruited in this study and Mann-Whitney U test was used to com-
randomly divided into two groups fifteen pare the effect of different treatments on
in each. The first group (the control) re- postoperative trismus and pain. Statisti-
ceived postoperative paracetamol tablets, cal analysis was performed using SPSS 19
a maximum of 4, 500 mg when needed. computer software program (SPSS, Cary,
The second group (the experimental) re- North Carolina, USA). Eight males and
ceived a postoperative muscle relaxant/ twenty-two females were recruited in this
analgesic capsule (Chlorzoxazone 250 mg study with a mean age of 25 ranged from
+ Paracetamol 300 mg) three times daily (18- 32) years old. The median of opera-
for seven days to ensure complete recov- tions time was 36 minutes for the con-
ery of the complicated cases. Interincisal trol group and 42 minutes for the treated
distance to assess the mouth opening was group and there was no significant differ-
measured before and after the surgical ence, p=0.197, between the two groups
procedure to assess trismus after the op- at p-value ≤ 0.05. Tooth sectioning in-
eration and these readings was measured volved eight cases compared to twenty-
postoperatively at different time intervals two teeth extracted without sectioning.
first, the third and seventh day. No correlation was found between time of
operation/tooth sectioning and postoper-
Surgical procedure ative trismus/pain.
The study was conducted at the Depart-
ment of Oral and Maxillofacial Surgery, Results
University of Mosul. Local anesthesia was Demography
administered through the inferior dental Eight males and twenty-two females were
block and buccal infiltration. A full-thick- recruited in this study with a mean age
ness mucoperiosteal flap is used in expos- of 25 ranged from (18-32) years old. The
ing all impacted lower wisdom teeth. Tooth median of operations time were 36 min-
sectioning is applied in difficult inclined utes for the control group and 42 minutes
teeth to facilitate their removal without for the treated group and there was no
traumatic injury to the adjacent structures. significant difference, p=0.197, between
Chlorhexidine solution 0.2 % used to clean the two groups at p-value ≤ 0.05. Tooth
and disinfect the area following complete sectioning involved eight cases compared
removal of impacted teeth. Suturing of the to twenty-two teeth extracted without
area done with 3/0 black silk suture. sectioning. No correlation was found be-
tween time of operation/tooth sectioning
and postoperative trismus/pain.
Postoperative assessments and sta-
tistical analysis
Postoperative measurement of the mouth
opening was performed, to assess trismus,
by measuring the Interincisal distance.40
Waseem Kh. Mahmood, Saif S. Ali Al-Jewari & Zaid A. Muhammad Volume 8, Issue 1, 2021
Trismus assessment Pain assessment
The median for Interincisal distance for Pain measured zero for all recruited pa-
control and treated group patients preop- tients. Paracetamol 500 mg didn’t show to
eratively were 44 for both groups (Table 1). provide enough analgesic effect following
Both medication formulae demonstrated a extraction of the impacted lower wisdom
significant effect following assessment of teeth. On the other hand, the combined
mouth opening postoperatively. There was formula medication tablet (Chlorzoxazone
no significant difference preoperatively in 250 mg with paracetamol 300 mg) dem-
mouth openings for those who recruited in onstrated an acceptable analgesic effect
this study who received later paracetamol compared with paracetamol 500 mg after
500 mg or Chlorzoxazone 250 mg with par- day 1 following the surgical procedure (Ta-
acetamol 300 mg (Table 2). Chlorzoxazone bles 3 and 4).
250 mg with paracetamol 300 mg demon- Table (3): Median of Visual Analogue Scale
strated a significant effect compared with (0-10) cm for pain assessment after adminis-
paracetamol only in relieving of postopera- tration of the above-mentioned two medica-
tive trismus following removal of impacted tions separately. Preoperative readings were
lower wisdom teeth (Table 2). zero (no pain).
Table (1): Median of mouth openings (Inter-
incisal Distance mm), after administration of
the above mentioned two medications sepa-
rately.
Table (4): P values for comparative effect of
the two medications on relieving of pain fol-
lowing removal of lower impacted wisdom
teeth. P value significant ≤ 0.05.
Table (2): P values for the comparative effect
of the above-mentioned two medications on
relieving of trismus following removal of
lower impacted wisdom teeth. P value sig-
nificant 0≤0.5.
Discussion
Noninfectious pain, trismus, and swelling
are commonly expected sequelae after
third molar surgery. Surgeons usually tend
to stress such complications when pre-
paring informed consents or sheets with
postoperative instructions. Patients seem41
Waseem Kh. Mahmood, Saif S. Ali Al-Jewari & Zaid A. Muhammad Volume 8, Issue 1, 2021
to focus more attention on functions like to the obvious improvement of postop-
chewing, swallowing, and eating. (Martin erative sequelae noted. According to
et al, 2005; Esteller-Martinez et al, 2004). two clinical trials published before 1980,
It is crucial that relieving post-operative combination therapy of Chlorzoxazone
pain should be effective and the side ef- and Paracetamol were more powerful in
fects should be reduced by using com- reducing pain than carisoprodol+ aspirin
bination therapy with a different mecha- and methocarbamol + aspirin (Miller et
nism of action of drugs rather than using al, 1976; Gready et al 1976). Further-
a single drug (Kehlet et al, 2003; White more, Scheiner, (1976) conducted a trial
et al, 2005; Ong CK et al, 2010). In our comparing the analgesic effect of Chlor-
study, this reduction in pain intensity may zoxazone with diazepam they found that
be attributed to the reduction of muscle Chlorzoxazone was more effective than
spasms caused by surgical trauma. So the diazepam in reducing pain and muscle
vicious cycle of (pain-trismus) can be in- spasm. In contrast to study research
terrupted by providing muscle relaxation. conducted by Nelson et al, (2016), where
Besides, the surgical removal of impacted they observed that there was no signifi-
teeth procedure is not traumatic as spi- cant reduction of early acute lower back
nal surgery procedure. To the best of the pain following spinal surgery by using a
authors’ knowledge, this work is the first single dose of Chlorzoxazone. Regarding
clinical study to evaluate the use of com- Chlorzoxazone safety, hepatotoxicity is
bined therapy (Chlorzoxazone 250 mg + the most concerning side effect. Howev-
Paracetamol 300 mg), in relieving post- er, this tends to occur rarely especially in
operative pain and trismus after surgical high doses with prolong use of the drug
removal of lower wisdom teeth compared (Jackson et al, 2007; Waldman et al,
with (paracetamol 500 mg). When pa- 1974). Furthermore, addiction is not re-
tients did not receive any analgesia medi- ported in patients using this drug (Jack-
cations, they show a high pain score on son et al, 2007) .in our study there is no
VAS, therefore our study design did not remarkable side effects were noted be-
involve the placebo group, because anal- cause of using a low dose of the drug for a
gesic is critical in such a procedure. The short period. The relation between swell-
main finding is that Chlorzoxazone 250 ing and trismus reduction is yet not fully
mg with paracetamol 300 mg showed sig- understood (why there was the reduction
nificantly less trismus and more ability to in swelling when using a muscle relaxant)
open their jaws than paracetamol only in so further research must be conducted to
both early (1 to 3 days) after surgery and study the relation between muscle re-
late (4 to 7 days) after surgery. There was laxants and postoperative swelling and
a significant decrease in pain (measured comparing it to other anti-inflammatory
by VAS) in all postoperative days (1st, medicines.
3rd, and 7th, postoperatively) in the com-
bined treatment group compared with the Conclusions
control group. Evaluation of trismus was The result of our study could justify us-
done by measuring Interincisal distance: ing a combination of Chlorzoxazone 250
a non-invasive, simple, cost-effective, and mg with paracetamol 300 mg as a good
time-saving method, which provides nu- alternative to the other pharmacological
meric data. The significant positive effect agents that relieve postoperative trismus
of the combination of Chlorzoxazone with (like steroidal and non-steroidal anti-in-
paracetamol on this study can be related flammatory agents).42
Waseem Kh. Mahmood, Saif S. Ali Al-Jewari & Zaid A. Muhammad Volume 8, Issue 1, 2021
Conflict of interest Esteller-Martinez V, Paredes-Garcia J, Val-
We are the author’s (Waseem Khalid maseda-Castellon E, Berini-Aytes L, Gay-
Mahmood BDS, MSc; Saif Saad Ali Al-Jew- Escoda C (2004). Analgesic efficacy of
ari BDS, FIBMS; Zaid Abdulazeez Muham- diclofenac sodium versus ibuprofen follow-
mad BDS, MSc stated that the manuscript ing surgical extraction of impacted lower
for this paper is original, and it has not third molars. Med Oral Patol Oral Cir Bu-
been published previously (or part of MSc. cal; 9:448-53 https://pubmed.ncbi.nlm.
dissertation or PhD thesis) and is not under nih.gov/15580123/.
consideration for publication elsewhere,
and that the final version has been seen Ghaeminia H, Hoppenreijs TJ, Xi T, Fennis
and approved by all authors. JP, Maal TJ, Berge SJ and Meijer GJ (2016).
Postoperative socket irrigation with drink-
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