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Aust Endod J 2012; 38: 3135

ORIGINAL RESEARCH

Prophylactic intraligamentary injection of piroxicam (feldene)


for the management of post-endodontic pain in molar teeth
with irreversible pulpitis
aej_274

31..35

Adnan Atbaei, DDS, MScD and Nazanin Mortazavi, DMD*


School of Dental Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Keywords
piroxicam, post-endodontic pain, prophylactic
intraligamentary injection, prospective study,
visual analogue scale.
Correspondence
Dr Nazanin Mortazavi, Farhang shahr, kooyeh
daneshgah, pelak 1, code posti 71879-63164,
Shiraz, Iran. Email:
mortazavi_nazanin@yahoo.com
doi:10.1111/j.1747-4477.2010.00274.x
*Present address: Farhang shahr, kooyeh
daneshgah, pelak 1, code posti 71879-63164,
Shiraz, Iran.

Abstract
The purpose of this prospective research was to evaluate the post-endodontic
pain-reducing effect of piroxicam (feldene), a non-selective non-steroidal antiinflammatory drug. Pain following endodontic treatment is often linked to the
inflammatory process as well as additional central mechanisms. The effects of
intraligamentary injection of piroxicam have not previously been studied.
Sixty-five patients with irreversible pulpitis were randomly divided into two
groups. The active group received intraligamentary injections totalling 0.4 mL
of piroxicam, while the placebo group received the same amount of lidocaine.
One-appointment endodontic therapy was performed by a single endodontist.
Visual Analogue Scale was used to record pain before treatment and 4, 8, 12,
24 and 48 h postoperatively. The decrease in the intensity of post-treatment
pain between the two groups was very significant. Intraligamentary injection
of piroxicam can be considered an effective method for reducing postendodontic pain.

Introduction
Pain following endodontic treatment is one of the most
widely studied topics in endodontics. Post-endodontic
pain results from instrumentation and/or obturation of
the canal(s) (1). Pain is usually more intense in the first
48 h and progressively reduces (if present) with time
until usually disappearing after 710 days (2). Although
the pain may not indicate endodontic failure, relief of this
pain is often more important to the patient than the
success or the failure of the treatment (3). The pain relief
afforded by endodontic treatment is usually effective, but
rarely immediate and complete. Post-treatment analgesics are required in a variable percentage of endodontic
cases. Long-acting local anaesthetics block the propagation of impulses along the peripheral nerves. Opioids
block central mechanisms of pain perception and
hyperalgesia. Non-steroidal anti-inflammatory drugs
(NSAIDs) and glucocorticoids control pain through blocking the inflammatory mediators (4). The inhibition of the
inflammatory process is one of the methods to reduce or
prevent pain during and after treatment. NSAIDs have

2010 The Authors


Australian Endodontic Journal 2010 Australian Society of Endodontology

been the traditional treatment for moderate pain. They


act primarily through the inhibition of cyclooxygenase
(COX) enzymes 1 and 2. Inhibiting COX-2, blocks prostaglandin formation and ultimately prevents inflammation and sensitisation of the peripheral nociceptors (5).
Double-blind clinical trials have shown that an NSAID,
ketorolac tromethamin, when injected intraorally or
intramuscularly, produces significant analgesia in patients
with severe odontogenic pain prior to definitive treatment. The intraoral (mandibular infiltration) injection of
ketorolac produced twice as much pain relief when compared with intramuscular injection of the same dosage of
the NSAID. It is also postulated that the intraligamentary
injection enables the application of anti-inflammatory
agents in the periapical intraosseous region (6,7). Early
comments on ketorolac included single dose efficacy
greater than that of morphine or petidine in moderate to
severe post-endodontic pain. There were fewer adverse
effects than when opioids were administered (8). Ketorolac 60 mg mL-1 provided significantly more pain relief
than did placebo at 12 and 24 h after some endodontic
procedures (9).
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Intraligamentary Injection of Piroxicam

Another NSAID, piroxicam has a half-life of 50 h in the


plasma. Oral piroxicam reaches peak concentration in
plasma within 2 to 4 h (10).
To date, no study has evaluated the efficacy of an
intraoral injection of piroxicam. The purpose of the
present study was to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain
associated with endodontic procedures.

Materials and methods


Sixty-five patients (29 women and 36 men), were
selected from the private outpatient clinic, School of
Dental Medicine, Shiraz University of Medical Sciences.
The research protocol was reviewed and approved by the
Ethics Committee of Shiraz University of Medical Sciences. The research protocol conforms to the provisions
of the Declaration of Helsinki.
Inclusion criteria for selecting volunteers were:
1. Healthy persons (ASA-I or ASA-II) who signed a
human subject committee approved consent form;
2. Acute symptomatic irreversible pulpitis of the first or
second molar teeth of either jaw;
3. Vital teeth with no history of previous root canal
therapy;
4. Teeth that could be treated endodontically in one visit;
5. Teeth with normal periodontium which were not sensitive to percussion and had no periapical radiolucency.
Exclusion criteria included:
1. Known hypersensitivity to piroxicam;
2. Pregnancy or lactation;
3. Child patients who developed asthma or allergy to
other anti-inflammatory drugs;
4. History of peptic ulceration;
5. Less than 14 years and more than 65 years of age.
Patients were assigned their study numbers as they
sequentially entered the study. A randomised code determined whether drug or placebo was assigned to each
patient and the code was not broken until completion of
the study. Neither the patient nor the independent investigator was aware of whether placebo or drug was
injected. Thus the experimental design was kept prospective, random and double-blind.
All the root canal treatments were carried out by a
single endodontist. All teeth (30 maxillary and 35 mandibular) were anaesthetised with standard injections
(block and/or infiltration) with 1.8 mL of 2% lidocaine
containing 1:80 000 epinephrine. The intraligamentary
injection was administered after the onset of a profound
local anaesthesia which was verified by lack of response
to electric sensibility testing, heat and cold tests. An intrapulpal injection was administered in cases where sensation was experienced during access cavity preparation.
32

A. Atbaei and N. Mortazavi

Thirty-five patients then received supplemental intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam
(Roxicam OSVAH Co. Tehran, Iran) as an active drug
and 30 patients received supplemental intraligamentary
injection of 0.4 mL of 2% lidocaine carpule containing
1:80 000 epinephrine (Persocaine-E DAROU PAKHSH
Co. Tehran, Iran) as an active placebo.
The needle was placed in the gingival sulcus at a
30-degree angle to the long axis of the tooth, with the
bevel facing away from the tooth. Apical pressure was
applied until the needle was wedged into the periodontal
ligament between the tooth and the alveolar crest of the
bone. The injection was delivered as 0.2 mL on the mesial
aspect of the target tooth and 0.2 mL on the distal aspect,
using a high-pressure special ligamental syringe with a
27-gauge short disposable needle. Piroxicam cartridges
were prepared prior to the study in a sterile manner, by
removing the rubber plungers from the standard anaesthetic cartridges, which were emptied, washed with tap
water and then autoclaved. The method of preparation of
the piroxicam cartridges was identical to the method as set
out in Elsharrawys article on supplemental intraligamentary injection of Fentanyl and Mepivacaine (11). Empty
sterile anaesthetic cartridges were filled with 0.4 mL
piroxicam at a concentration of 20 mg mL-1, extracted
from piroxicam vials. Lidocaine as the active placebo was
used in its original (indistinguishable) dental carpule.
In each case, after administration of local anaesthesia
and supplemental intraligamentary injection, an access
cavity was prepared. Root canal preparation (using stepback technique) was achieved with hand files under
copious irrigation of sterile saline solution. This preparation was continued to a size that would allow an
acceptable lateral condensation gutta-percha filling technique to be performed using zinc oxide-eugenol as
sealer. After root canal obturation, a dry cotton pellet
was placed in the chamber followed by Cavit temporary
filling and the occlusion was evaluated to ensure there
were no interferences.
A Visual Analogue Scale (VAS), which is a standard tool
for rating pain, was used in this study. At the completion
of treatment, each patient was handed an evaluation
sheet and the VAS was explained to the patient. The
severity of any pain was self-assessed by patients before
treatment and 4, 8, 12, 24, 48 h following completion of
treatment. Pain was defined as the presence of any degree
of discomfort and was scored from 0.1 to 10 (on a scale of
0 to 10). Patients were requested to stop taking analgesics
prior to treatment with the proviso that if pain were to
persist or recur, oral analgesics could be taken. They were
also instructed that the next pain score should be marked
relative to the amount of pain they experienced before
taking oral analgesics.

2010 The Authors


Australian Endodontic Journal 2010 Australian Society of Endodontology

Intraligamentary Injection of Piroxicam

A. Atbaei and N. Mortazavi

Statistical analysis was performed with the use of the


independent t-test, chi-squared tests and Repeated
Measure Multivariate Analysis by using SPSS software.
P-values of 0.05 were used to indicate significant
differences.

Discussion
Reports of post-endodontic pain are still heard following
root canal therapies. According to a prospective study by
Georgopoulou et al., pain-free patients do not succeed in
57% of all endodontic cases (12). Adequate local anaesthesia eliminates most of the pain during treatment, but
considerable discomfort is expressed occasionally following an endodontic treatment (13). According to Harrisson
et al. (14), postoperative pain was more likely to occur
in symptomatic patients within the first 24 h following
root canal therapy. Several systematic reviews have
demonstrated that NSAIDs produce excellent analgesic
responses in patients who can tolerate this class of drugs.
There exists strong evidence for the use of NSAIDs as a
primary class of analgesics for treating acute inflammatory pain because of either surgical or non-surgical endodontic procedures (15). The onset of action of oral
piroxicam is 24 h, but it is anticipated that injectable
piroxicam could produce more rapid onset of action
(7,10). Besides, the effect of endodontic treatment itself,
the floor effect (15), would overlap this time gap. Piroxicams half-life of 50 h, could favourably overcome the
intense pain up to 48 h following the treatment (2,10).
The effect of supplemental intraligamentary injection was
initially excluded from the study by applying intraligamentary injection of piroxicam or lidocaine to either
group. The results obtained would then be attributable to
the pharmacological effect of piroxicam or lidocaine per
se. Fewer incidents of adverse effects have been reported
using intraligamentary injection. Most incidents resulted
from poor operator technique (16).

Results
Over a period of 15 months, patients were screened for
possible participation in the study. A total of 65 patients
were included in the study.
The similarity of groups, were confirmed by analysing
preoperative pain intensity distribution. There was
no significant difference regarding the baseline
(preoperative) pain intensity between two groups
(P = 0.912).
The intensity of pain in the piroxicam and placebo
groups at each time interval is presented in Figure 1. In
both groups, statistically significant decrease in postoperative pain intensities existed (P = 0.000).
Statistically, a significant reduction of postoperative
pain intensity was found in the group that received
piroxicam compared with the placebo group at all times
recorded after 4 h (P = 0.025), after 8 h (P = 0.001),
after 12 h (P = 0.002), after 24 h (P = 0.011) and after
48 h (P = 0.031). Mean pain relief over time for each
group is shown in Figure 2.
Multivariate tests showed that there was no interaction effect between group and time (P = 0.129) and significant changes over time (P = 0.000) were observed.
There was no reported clinically adverse effect in either
group.

10
9
Piroxicam
Placebo

Pain intensity on VAS

8
7
6

5.737
5.647

5
4

3.69

3.553

3.04

2.433
1.806

1.19

1
0

Before

0.754

12

0.503
24

1.96
0.27
48

Time (h)
Figure 1 Mean pain intensity of piroxicam and placebo groups rated on a 010 visual analogue scale (VAS) at each time interval.

2010 The Authors


Australian Endodontic Journal 2010 Australian Society of Endodontology

33

Intraligamentary Injection of Piroxicam

A. Atbaei and N. Mortazavi

Means of pain relief

2.00
Placebo (n = 30)
Piroxicam (n = 35)

3.00

4.00

5.00

12
Time (h)

24

48

Figure 2 Means of pain relief at each time interval after intraligamentary injection in piroxicam and placebo groups.

Remarkable pain-reducing effect of intraoral piroxicam, observed in the present clinical trial, recalled the
analgesic effect of ketorolac in the study of Penniston and
Hargreaves. The intraoral injection of ketorolac was considered as a useful adjunct in the management of endodontic pain patients (7). The difference between the
present trial with that of Mellor, Dorman and Girdler (17)
was that, in the present study a standard primary anaesthetic technique was established before intraligamentary
injection of piroxicam. Contrarily, the test group in the
latter study received standard anaesthesia 15 min after
ketorolac (another NSAID) infiltration injection. This
may explain the discomfort observed at the injection site.
Patients in the test group of the present trial did not
complain of such a discomfort.
VAS is quantitative, yet is a subjective method for
scoring pain. It was chosen as it was thought that it
would allow better comparison with other studies
(2,18). Similar to pain scale of Kaufman et al. who
studied a slow-release methyl prednisolone (16),
patients in the present study defined pain as the presence of any degree of discomfort on a scale of 010.
Both studies indicated that post-treatment pain reduction occurred after an intraligamentary injection of the
supplemental analgesic. Continuation of pain up to 48 h
in the present trial was similar to findings of Mattscheck
et al. (19) and also in favour of Ng et al. (20), who
reported a VAS of 05. In the present study, the decreasing trend of pain intensity from baseline until 48 h posttreatment existed in both placebo and experimental
group (Fig. 1). The significant postoperative difference
between the mean VAS of the two experimental groups,
from 4 h to 48 h (Fig. 2), is a positive sign for the analgesic effect of piroxicam.
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Conclusion
Prophylactic intraligamentary injection of 8 mg of piroxicam is highly effective for reducing post-endodontic pain
for vital teeth with irreversible pulpitis during the first
48 h. It was much more effective than a similar lidocaine
injection in reducing postoperative endodontic pain.

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Australian Endodontic Journal 2010 Australian Society of Endodontology

Intraligamentary Injection of Piroxicam

A. Atbaei and N. Mortazavi

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