Comparison of oral and sublingual piroxicam for management of postoperative pain after mandibular third molar surgery: A prospective, randomized study

Shruti Shashikant Phulgirkar; Lingaraj J Balihallimath

doi:10.4103/2349-5006.191250

ORIGINAL ARTICLE

Year : 2016 | Volume : 9 | Issue : 2 | Page : 142-146

Comparison of oral and sublingual piroxicam for management of postoperative pain after mandibular third molar surgery: A prospective, randomized study

Shruti Shashikant Phulgirkar, Lingaraj J Balihallimath
Department of Maxillofacial Surgery, KLE VK Institute of Dental Sciences, Belgaum, Karnataka, India

Date of Web Publication

29-Sep-2016

Correspondence Address:
Shruti Shashikant Phulgirkar
Department of Maxillofacial Surgery, KLE VK Institute of Dental Sciences, Nehru Nagar, Belgaum, Karnataka
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/2349-5006.191250

Abstract

Background and Objectives: Surgical extraction of the third molars has been one of the widely performed procedures of all the minor oral surgical procedures in oral and maxillofacial surgery. Inflammation is a critical part of the normal sequence of healing as well as is an important cause for postoperative sequelae. They include pain, restriction of mouth opening, and swelling which are a few reasons for discomfort to the patient. There are various measures for the management of these complications including administration of nonsteroidal anti-inflammatory drugs. This study was done to compare the clinical efficacy of oral and sublingual piroxicam in the management of postoperative pain after surgical removal of the lower third molars.
Methodology: The study comprised thirty selected patients with bilaterally impacted mandibular third molars. Split-mouth study design was implicated such that the patients served as their own control. Group 1 consisted of patients who were given piroxicam orally, and Group 2 consisted of patients who were given sublingual preparation postoperatively. Subjective evaluation (visual analog scale) and objective evaluation (validated landmarks) were carried out for pain, swelling, and trismus for the postoperative days 1 ^st , 3 ^rd , and 7 ^th .
Results: The results showed no significant differences with respect to postoperative pain, trismus, and swelling when the two routes of drug delivery, namely, oral and sublingual were compared. Furthermore, the amount of rescue analgesics taken was slightly higher in the oral group but not statistically significant.
Conclusion: Within the limitations of the study, it can be concluded both oral and sublingual formulations of piroxicam show comparable results and that both are equally effective in the postoperative management of pain, trismus, and swelling after surgical removal of the third molar.

Keywords: Impaction, nonsteroidal anti-inflammatory drug, sublingual and oral piroxicam

How to cite this article:
Phulgirkar SS, Balihallimath LJ. Comparison of oral and sublingual piroxicam for management of postoperative pain after mandibular third molar surgery: A prospective, randomized study. Indian J Health Sci Biomed Res 2016;9:142-6

How to cite this URL:
Phulgirkar SS, Balihallimath LJ. Comparison of oral and sublingual piroxicam for management of postoperative pain after mandibular third molar surgery: A prospective, randomized study. Indian J Health Sci Biomed Res [serial online] 2016 [cited 2022 May 17];9:142-6. Available from: https://www.ijournalhs.org/text.asp?2016/9/2/142/191250

Introduction

The surgical removal of impacted third molars is one of the most common minor oral surgery procedures widely carried out in general practice and also occupies an appreciable amount of clinical time in many hospitals in oral and maxillofacial departments. ^[1] The decision to remove third molar is often difficult because of the consequences of the surgical extraction. Patients complain of pain, swelling, and limitation of mouth opening. ^[2]

Sublingual administration of the drug avoids the first passage of drug in liver, unlike oral administration. Furthermore, orally administered nonsteroidal anti-inflammatory drugs (NSAIDs) pass through the gastrointestinal tract causing disturbances, whereas sublingual administration avoids that. ^[3]

In this study, we have compared the clinical efficacy of piroxicam, administered orally and sublingually, for the management of postoperative pain and trismus and swelling after surgical removal of the lower third molar.

Aim

The aim of the study is to compare the efficacy of sublingual and oral piroxicam for the management of postoperative pain after the mandibular third molar surgery.

Objectives

Assess the clinical efficacy of piroxicam given sublingually and orally for the relief or prevention of postoperative pain after the surgical extraction of the third molar
Assess the clinical efficacy of piroxicam given sublingually and orally for the relief or prevention of postoperative swelling after the surgical extraction of the third molar
Assess the clinical efficacy of piroxicam given sublingually and orally for the relief or prevention of postoperative trismus after the surgical extraction of the third molar
Assess the amount of rescue analgesic taken in both the cases of orally and sublingually administered piroxicam.

Study population

Thirty patients, between the age-group of 18-40 years, who require to undergo the surgical extraction of the impacted mandibular third molar, reporting to the Department of Oral and Maxillofacial Surgery at KLE VK Institute of Dental Sciences, Belgaum, were included in the study.

Study design

A prospective, randomized study was conducted on a clinical series of thirty patients:

Group 1 (30) - Oral piroxicam was given
Group 2 (30) - Sublingual piroxicam was given.

Sample selection

Thirty randomly selected patients, with bilateral mandibular impacted third molars, diagnosed by established clinical and radiographical parameters, each of the lower third molar being randomly placed in two groups, namely, oral and sublingual piroxicam, irrespective of age, sex, difficulty in impaction, and their response to various drugs to eliminate bias.

Inclusion criteria

Patients who will undergo surgical extraction of bilaterally impacted mandibular third molar teeth, between the age-group of 18-40 years
Compliant patients.

Exclusion criteria

Medically compromised patients
Patients unwilling to participate in the study
Patients allergic to aspirin, piroxicam, or any other NSAID and local anesthetic
Pregnant women or women in the breastfeeding period.

Procedure

Case history of the patient was taken before the commencement of surgical extraction of the mandibular third molars. Assigned patients underwent surgical procedure in the Oral Surgery Unit by a single experienced surgeon. Only one side of the jaw was operated at a time. The standard protocol is followed for the surgical extraction of the impacted teeth. All patients received postextraction instructions. Moreover, following the extraction, the patient was given piroxicam either sublingually or orally. Patients were randomly given drug by either oral or sublingual (opaque envelope method). Each patient remained unaware of how piroxicam would be administered after the first surgery was completed. The NSAID administration protocol was one 20 mg tablet of piroxicam taken orally or one 20 mg tablet of fast-dissolving piroxicam taken sublingually, twice daily for 2 days and once daily for the next 4 days. Oral rescue analgesic, diclofenac sodium, was prescribed, and the patients were asked to record the date and time at which it was consumed. They were instructed not to interrupt the use of the principal medication even if they had consumed rescue analgesic medication. After surgery, the patients were asked to score overall pain on a 10-point visual analog scale (VAS) (VAS: 0 - no pain; 10 - agonizing pain) after the surgery (within 90 min), 3 ^rd day, and 7 ^th day postoperatively. The level of facial swelling was determined by the distance in millimeter between the following landmarks:

Palpebral external angle and gonial angle of the operated side, known as angle of eye-angle of the jaw (AE-AJ)
Lower margin of the tragus to the external angle of the buccal commissure, known as tragus-angle of the mouth (T-AM)
Lower margin of the tragus to the middle point of the symphysis menti, known as tragus-pogonion (T-P) [Figure 1].

Trismus was evaluated by measuring mouth opening preoperatively and the 1 ^st , 3 ^rd , and 7 ^th days postoperatively by measuring distance between the mesioincisal corners of the upper and lower right central incisors at maximum opening of the jaws. The same antibiotics were prescribed to all the patients. Half-life of the drug is 2 days. Therefore, the patient was recalled after 15 days for the removal of the tooth on the other side.

Figure 1: Palpebral external angle and the gonial angle of the operated side, known as angle of eye angle of jaw (AE-AJ). Lower margin of the tragus to the external angle of the buccal commissure, known as tragus angle of mouth (T-AM). Lower margin of the tragus to the middle point of the symphysis menti, known as tragus pogonion (T-P)^[4]

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Statistical analysis

Mann-Whitney U-test
Chi-square test
P < 0.05 was considered statistically significant.

Results

The study showed comparable results when pain, swelling, and mouth opening on the postoperative days 1, 3, and 7 were compared. The rescue analgesics taken were slightly higher in Group 1 (oral piroxicam) than in Group 2 (sublingual piroxicam) but not statistically significant (P = 0.0678) [Table 1] and [Table 2], [Graph 1 and 2].

Table 1: Comparison of oral and sublingual groups with respect to pain scores at different time points by Mann-Whitney U‑test

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Table 2: Comparison of two groups (oral and sublingual) with rescue analgesic taken

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Discussion

The complications occurring after surgical extraction of the third molars can be broadly divided into major and minor complications. Complications that require further additional treatment and may result in irreversible consequences are known as major complications. ^[5] On the other hand, complications that can recover without any further additional treatment are reversible and are known as minor complications. These mainly include postoperative swelling, pain, and trismus. ^[6],[7]

The extent of pain and swelling are the chief indicators of patient's comfort during postoperative recovery period. The main contributors for postoperative facial swelling are the duration and difficulty of the surgical procedure. Although the effect of gender and age is still controversial. ^[8],[9]

In this study, swelling and pain were subjectively evaluated by VAS, and objective evaluation of swelling was done by validated landmarks. Trismus was evaluated by measuring the distance between the mesioincisal corners of the upper and lower right central incisors at maximum opening of the jaws preoperatively, on the 1 ^st , 3 ^rd , and 7 ^th postoperative days. ^[2]

The level of facial swelling was determined by a modification ^[10] of tape measuring method described by Gabka and Matsumura. ^[11] Three measurements were made between five reference points: Tragus, soft-tissue pogonion, lateral corner of the eye, angle of the mandible, and outer corner of the mouth, preoperatively and on the 2 ^nd and 7 ^th postoperative days. Photographic techniques have also been applied to measure the anatomical changes in the patients' profiles undergoing third molar surgery. ^[12]

The sublingually administered drug is absorbed across the oral mucosa and thus avoids gastrointestinal and/or hepatic degradation before entry into the systemic circulation, unlike orally administered drugs. Sublingual formulations are therefore considered more effective than oral ones. Oral mucosal lining is the preferred route for the local and systemic administration of a few selected drugs. ^[13] The advantages over the other routes of drug delivery, enteral and parenteral, include its rich blood supply, fast onset of action, improved bioavailability, avoidance of the first pass metabolism, and food effects. The sublingual dosage form of piroxicam used in this study showed no adverse effects.

A double-blind study was conducted to assess the efficacy of mefenamic acid and piroxicam in postexodontic pain relief by Ohnishi M, Kawai T, and Ogawa N. Single doses of piroxicam (20 mg) and mefenamic acid (500 mg) were divided into two groups and compared. The treatments statistically showed equivalent results and were highly successful; approximately 75% of the study and control groups reported a reduction of two or more points in pain intensity. The patients reporting complete relief of severe pain were on the higher side for piroxicam. Piroxicam was clearly efficacious in relieving pain after extraction. ^[14]

Desjardins PJ studied the analgesic efficacy of piroxicam formulations in management of postoperative dental pain and concluded that although neither piroxicam 5 mg nor 10 mg produced clinically significant analgesia, piroxicam that is available in 20 mg or 40 mg was significantly better to the placebo and was comparable with aspirin 648 mg over the first six postoperative hours. ^[15]

A review on single dose of piroxicam for management of acute postoperative pain was done by Moore RA, Edwards J, Loke Y, Derry S, and McQuay HJ. The number-needed-to-treat-to-benefit suggests that single doses of piroxicam (20 mg and 40 mg) are effective for treating moderate to severe postoperative pain and compare satisfactorily with opioid analgesics such as dextropropoxyphene and tramadol and other NSAIDs. Few side effects were reported, and piroxicam appears to be fairly well tolerated in this clinical context. ^[16]

This study assessed the clinical efficacy of the NSAID, piroxicam, administered either orally or sublingually, after the surgical extraction of the lower third molars under local anesthesia. The results of this study showed that piroxicam administered orally or sublingually would be effective in reducing inflammation and pain after the surgical extraction of the lower third molars.

Within the limitations of the study, it can be concluded that postoperative pain, trismus, and swelling in patients subjected to surgical extraction of the lower third molars can be controlled successfully by 20 mg of piroxicam administered either orally or sublingually.

Conclusion

The study showed that both formulations of piroxicam showed comparable results in the management of postoperative sequelae of pain, trismus, and facial swelling of surgical extraction of the lower third molars. The amount of rescue analgesics taken was higher in Group 1 as compared to Group 2, but the results are not statistically significant. To conclude, both the drugs were efficacious in the management of postoperative sequelae, irrespective of the routes of their drug delivery. Thus, both formulations can be used effectively to control the pain, trismus, and swelling after surgical extraction of the lower third molars.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s)has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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