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versão impressa ISSN 1698-4447
Med. oral patol. oral cir. bucal (Ed.impr.) vol.10 no.5 Nov./Dez. 2005
Analgesic efficacy of diclofenac versus methylprednisolone in the control of postoperative pain after surgical removal of lower third molars
Eficacia analgésica de diclofenaco versus metilprednisolona en el control del dolor postoperatorio
tras la cirugía del tercer molar inferior
Carmen López Carriches (1), José Mª Martínez-González (2), Manuel Donado Rodríguez (3)
(1) Profesora asociada de Odontología Integrada de Adultos
de la Universidad Europea de Madrid
(2) Profesor titular de Cirugía Maxilofacial de la Universidad Complutense de Madrid
(3) Catedrático de Patología Quirúrgica Oral y Maxilofacial de la Universidad Complutense de Madrid
Dra. Carmen López Carriches
C/. Rey Francisco, 11. Bajo izda
Tlf/fax: 91 5422507
Received: 27-02-2005 Accepted: 12-06-2005
López-Carriches C, Martínez-González JM,
Donado-Rodríguez M. Analgesic efficacy of diclofenac versus
methylprednisolone in the control of postoperative pain after
surgical removal of lower third molars. Med Oral Patol Oral Cir Bucal
Objetive: To compare the analgesic efficacy of methylprednisolone (corticoid) versus diclofenac (nonsteroidal antiinflammatory-NSAID-) after surgical removal of lower third molars.
Key words: Oral surgery third molars, methylprednisolone, diclofenac, pain.
Objetivo: Comparar la eficacia analgésica de la metilprednisolona (corticoide) versus diclofenaco (antiinflamatorio no esteroideo-AINE-) tras la cirugía del tercer molar inferior.
Palabras clave: Cirugía del tercer molar, metilprednisolona, diclofenaco, dolor.
The surgical removal of lower third molars is a procedure generally followed by side effects such as postoperative pain, swelling and trismus (1).
The pain after the extraction of lower third molars is one of the most representative models of postoperative pain and it is frequently used for the evaluation of analgesic drugs (2,3). According to literature (4,5), pain after the surgical extraction of a third molar is more acute during the first 12 hours, reaching its highest intensity 6-8 hours after surgery.
A lot of research has been done on drugs to minimize postoperative pain: the most used ones are the NSAID, that inhibit the synthesis of prostaglandins and tromboxans, reducing their action on sensitive terminations, as well as their chemotactic and vessels dilating actions (6). Among them, diclofenac has showed its efficacy in several studies (7,8). Here are also many studies about the treatment with corticosteroids (9-11), but their usage is still controversial because of their possible side-effects. There is a potential risk for complications due to the use of these drugs, such as adrenal suppression, cicatrisation delay and infection (12).
The objective of this study is to evaluate the differences between the use of diclofenac and the use of methylprednisolone in the treatment of pain after the surgical removal of lower third molars.
PATIENTS AND METHOD
A clinic study that was controlled, prospective, at random and double-blind was carried out in Phase IV on 73 patients who came to the Oral Surgery Unit (Department of Medicine and Oral Surgery) in the Faculty of Odontology of the Universidad Complutense de Madrid for the surgical removal of their lower third molars. This study lasted one year.
Inclusion criteria were as follows: patients with ages between 18 and 42, who gave their consent to participate in the study and who signed the informed consent, without systemic pathology and without clinical symptoms in the third molar.
Exclusion criteria were the following: patients with systemic pathology, pregnant women o women in the breastfeeding period and patients with symptomatology in the third molar or who have taken some anti-inflammatory 7 days before.
Two groups were formed by random assignment.: The 36 patients in group A took oral diclofenac sodium (Voltaren®) at doses of 50 mg every 8 hours during the first three days after surgery; and the 37 patients in group B took oral methylprednisolone (Urbason®) at doses of 4 mg every 8 hours also during three days. All patients received antibiotic treatment with oral amoxicilin at doses of 750 mg every 8 hours during 7 days after surgery. Those who still have pain may request the oral administration of a rescue drug called magnesium metamizol (Nolotil®) at doses of 575 mg every 6 or 8 hours for pain relief. The number of capsules ingested by each patient was included among the assessment parameters.
Several side effects were assessed, such as nausea, vomiting, headache, gastrointestinal pain, cicatrisation delay, infection, etc.
The clinical procedure was carried out in a regulated manner and always by the same surgeon.
Pain assessment was made by an analogical visual scale (AVS) at 1, 8, 24, 48 and 72 hours and by a semiquantitative scale (absent, mild, moderate or severe) during the first five days. The correlation between both scales was stablished by an statistic. Likewise, each patient was asked to write down the number of rescue analgesics consumed for pain relief during the first five days.
The statistical assessment was made in the Data Processing Center of the Universidad Complutense de Madrid, where BMDP program was used BMDP, making a detailed description of data, tables of frequencies, bivariant graphics, t-Tests and repeted measures analysis of variance. For quantitative or continuous variables, Students t-Test (parametric test for comparing means) and Mann-whitney test (non-parametric test) were used. Chi-square test and Yates correction were used for qualitative or categorical variables.
It was discovered that samples were homogeneous in age, sex, side of surgery, position of the third molar and duration of surgery.
The average age in the methylprednisolone group was 23.4 and in the diclofenac group 23.6, being that not a significant difference (Students t-test=0.866; Mann Whitney test=0.665)
In relation to the sex of the patients, 73% were women and 27% men in the methylprednisolone group. In the diclofenac group, 52.8% were women and 47,2% men. Chi-square test (P=0.07) and Yates correction (P=0.122) were used for qualitative or categorical variables. It was confirmed that there were no significant differences between both groups.
In the methylprednisolone group the side of surgery was the right side in 56.8% and the left side in 43.2%. In the diclofenac group it was distributed 50% to 50%, so, there were no significant differences about the side of surgery: Pearsons Chi-square test P=0.562 and Yates correction P=0.730.
In what refers to the position of the third molar, three positions were considered in relation to the second molar axial axis: distal, vertical, mesial and horizontal. The position didnt affect the results because there were no significant differences in it (P=0.633).
And last, time was measured in minutes from the moment of the incision till the end of the suture in both groups. The average time was 11.4 minutes in the methylprednisolone group and 10.9 in the diclofenac group. There was not a significant difference, being the Students t-test 0.709 and the Mann-Whitney test 0.499.
The assessment of pain response by AVS let us observe that the most severe pain appeared after 8 hours, when the anesthesia wears off; after 24 hours the pain is less severe; and after 48 and 72 hours theres a different behaviour in each group. The difference is not significant (0.080) at 48 hours and significant at 72 hours (p=0.010), with more pain for patients of the diclofenac group. (Table 1)
Patients used a semiquantitative scale to describe their pain as absent, mild, moderate or severe. The pain intensity distribution during the first five days can be seen in table 2. The differences between both groups are statistically significant in days 4 and 5 (p<0.050), with less pain in the methylprednisolone group.
The number of rescue analgesics consumed decreases until the fifth day, that is, that the symtoms decrease in both groups. Patients in the diclofenac group needed more rescue analgesics from the second day, and this difference was statistically significant the third day (p<0.050). This difference can be seen in table 3. We also did a repeated measures analysis of variance. In the pain described by patients in the analgesic visual scale, there were no differences between both groups (but there were at certain moments-p=0,406-) but there were differences in time (p=0) and in the interaction effect (the slopes are not parallel-p=0,020-). (Figure 1)
In relation to the rescue analgesics consumed, we can observe in figure 2 how is the behaviour of the analgesic consumption variable in time in both groups. In this case, there were very significant differences in the different times registered (p=0) but not between groups as a whole (at certain moments, patients treated with methylprednisolone took less rescue analgesics) nor in the interaction effect (both curves are very similar).
For our study, we decided to use diclofenac for being it one of the most representative NSAID and one of the most used after the extraction of a lower third molar (13-15). We havent observed any side-effect during our study, while Joshi et al (7) found nausea, vomiting, headache, gastrointestinal pain. We have even found in literature a case of perforation of the colon with acute peritonitis after the intake of diclofenac and clindamicine (16). Ibuprofen has great support in literature (17-21) with a efficacy similar to that of diclofenac (7,14,17,18).
Steroids inhibit the transformation of the fatty acids in the cell wall into arachidonic acid, which is the source of the strongest substances (prostaglandins and leukotrienes). We have used methylprednisolone in our study because it is an steroid with antiinflammatory properties and very few counterindications: patients with active or inactive tuberculosis, glaucoma, diabetes mellitus and acute or chronic infection. There are several studies in which methylprednisolone is used to ease the pain after the extraction of the lower third molar, such as the one of Tiwana and collaborators (9), who use 40 mg intravenous methylprednisolone without antibiotics. Üstün et al (10), Esen et al (11), Schultze-Mosgauet et al (22) or Milles et al (23), among others, also use methylprednisolone after the extraction of the lower third molar. This preparation has an intermediate power, five times the power of Cortisol, low levels of salt retentionand an intermediate duration of action, between 12 and 36 hours. It is well-known that steroids suppress the inmune function increasing the potential risk of infection. We havent seen any case of infection during this treatment in neither of the groups because we used the glucocorticoid only for three days. A bigger sample and patients not treated with antibiotics are maybe necessary in order to assess the incidence of infection, with the profilaxis being a very controversial matter (24,25).
In relation to the results obtained in both groups, it is important to highlight that all samples were homogeneous in age, sex, side of surgery, position of the third molar, duration of surgery, so that the differences in postoperative cannot be related to the characteristics of the patient or those of the lower third molar.
We agree with authors like Norholt (2), Habid et al (26) and Bailey et al (27), who state that pain reaches its maximum level in the analogical visual scale between 3 and 8 hours after surgery. We observe the maximum pain at 8 hours, both in the corticoid group and the NSAID group (non-significant difference).
The repeated measures analysis of variance showed: no differences among groups in pain as measured by the analogical visual scale, significant differences in the time effect (p=0) and in the interaction effect (p=0.02). Both groups reacted in a different way in pain along time, that difference appearing at 48 and 72 hours. Nevertheless, in relation to the number of analgesics consumed, the difference was significant only in the time effect, but not in the group or interaction effects.
To summarize, we can conclude that there is no difference in pain until days 3 and 4. There is less pain in the methylprednisolone group; remember that patients took antiinflammatories only during the first three days, but methylprednisolone has an intermediate action (between 12 and 36 hours) and, therefore, its effects can continue until day 4. We tried to compare these results with those of other authors, but we found that those were done on different drugs, doses and administration routes, with placebo instead of corticoids and NSAIs and using different pain assessment systems and registry frequencies. Nevertheless, in a study which is very similar to ours on ibuprofen versus methylprednisolone, they found the same level of pain with both compounds (28).
We must bear in mind that besides the surgical trauma (measured by the duration of surgery), there are other factors with an influence on the postoperative pain level perceived: the surgeon, the sex of the patient and some psichological factors. Amin and Laskin (29) find no relation between pain and the duration of surgery, the depth or the angulation of the third molar. Bailey et al (27) finds no relation between pain and the type of colgajo or the amount of bone removed. and Fisher et al (5), and Northolt (2) demonstrated that the duration of surgery has nothing to do with the postoperative pain. We cannot forget that each patient shows a different response to surgical trauma.
There is a controversy about the apropriate moment to administer the antiinflammatory, with a tendence to do it before pain appears (7,28,30). This is very logical because, as said before, pain reaches its maximum level between 3 and 8 hours after surgery and at that time, the antiinflammatory should have reached a high concentration in plasma.
Patients treated with corticoids feel less pain, but not in such a significant way as to justify their rutinary use.
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