Preemptive rofecoxib and dexamethasone for prevention of pain and trismus following third molar surgery

doi:10.1016/j.tripleo.2004.08.028

Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology

Volume 99, Issue 2, February 2005, Pages E1-E7

https://doi.org/10.1016/j.tripleo.2004.08.028 Get rights and content

Objective

The goal of this preliminary randomized prospective clinical trial was to compare the analgesic efficacy and the reduction in trismus of preoperative rofecoxib, intraoperative dexamethasone, and both rofecoxib and dexamethasone following third molar extraction surgery.

Study design

Thirty-five subjects requiring surgical removal of at least 1 partial bony impacted mandibular third molar were invited to participate in this double-blind and double-dummy placebo-controlled clinical trial. Subjects were randomly assigned into 1 of 4 treatment groups: (1) placebo po preoperatively and placebo IV intraoperatively; (2) rofecoxib 50 mg po preoperatively and placebo IV intraoperatively; (3) placebo po preoperatively and dexamethasone10 mg IV intraoperatively; and (4) rofecoxib 50 mg po preoperatively and dexamethasone 10 mg IV intraoperatively. Subjects completed a diary assessing postoperative pain onset and intensity using categorical and visual analogue scales. Interincisal opening was assessed 1, 2, 3, and 7 days postoperatively using a Therabite ruler.

Results

This randomized controlled clinical trial enrolled 35 subjects. Two subjects did not meet the inclusion criteria and 4 did not return completed diaries. The mean age of the remaining 29 subjects (11 males, 18 females) was 22.8 years (± 0.6 year). The active treatments tended to delay the need for initial pain medication. When compared to other active treatments and to placebo, the combination of preoperative rofecoxib and intraoperative dexamethasone significantly reduced initial pain intensity (P < .05). Baseline interincisal opening was 52.6 mm (± 6.2). The greatest decrease in interincisal opening was 43.3% for the placebo group at 24 hours. Preoperative rofecoxib alone showed a decrease in interincisal opening of 42.3% (P = ns) at 24 hours. Intraoperative dexamethasone alone showed a decrease in the interincisal opening of 24.1% of baseline (P < .05 vs placebo). The group receiving the combination of rofecoxib and dexamethasone showed a decrease in interincisal opening of 23.7% of baseline (P < .05 vs placebo).

Conclusions

The results of this trial indicate that the use of intraoperative dexamethasone is an effective therapeutic strategy for limiting trismus following surgical removal of impacted third molars. The combination of preoperative rofecoxib 50 mg and intraoperative dexamethasone 10 mg was most effective in minimizing pain and trismus following third molar surgery.

Section snippets

Research design and methods

Thirty-five outpatients of the University of Pittsburgh School of Dental Medicine requiring extraction of at least 1 partial bony impacted mandibular third molar were invited to participate in this randomized, controlled, Insitutional Review Board (IRB)–approved clinical trial. Male and female subjects age 18 to 50 years were eligible to participate. Exclusion criteria included active infection immediately before surgery; use of other analgesics within 8 hours of surgery; a recent history of

Results

This randomized controlled clinical trial enrolled 35 subjects undergoing surgical extraction of third molars. Two subjects did not meet the inclusion criteria and 4 did not return or complete their 7-day diaries. There were no significant age, weight, or gender differences between treatment groups (P = ns). The mean age and weight of the remaining 29 subjects (11 males, 18 females) was 22.8 years (± 0.6) and 156.0 pounds (± 6.5). All subjects were classified as either aspirin I or II (Table I).

Discussion

Trismus, measured in this study as a decrease in maximal interincisal opening, is a significant postoperative sequalae caused by the edema and swelling associated with the surgical trauma.¹ Limitation of maximal mouth opening after surgery is also due, at least in part, to the associated pain. Rofecoxib alone, which was found to provide a slight reduction of postoperative trismus, may be acting primarily by reducing patient discomfort upon opening, thereby permitting greater extension of the

Conclusions

Results of this small, randomized controlled clinical trial indicate that intraoperative dexamethasone provides the most effective therapeutic strategy for limiting trismus following surgical removal of third molar teeth. The combination of dexamethasone and rofecoxib provided the greatest pain relief in the immediate postoperative period. Although prohibited in this clinical trial, the additional use of bupivacaine to manage postoperative pain would likely provide even further benefits for

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Cited by (72)

Is Injectable Platelet-Rich Fibrin Really Effective in Reducing Expected Side Effects of Removing Impacted Third Molar Surgery?
2024, Journal of Oral and Maxillofacial Surgery
Common side effects of third molar (M3) operations including pain, edema, and trismus have an adverse effect on patient quality of life. Injectable platelet-rich fibrin (i-PRF) may ameliorate some of the side effects of the operation.
The primary purpose of this study is to measure and compare differences in pain, swelling, trismus, and quality of life between i-PRF side and a control side of subjects undergoing M3 removal.
This study is a single-center, split-mouth, randomized prospective clinical trial conducted at Ordu University Faculty of Dentistry. Patients who presented between March and August 2022 for the extraction of impacted third molars due to various reasons were included in the study. The exclusion criteria were local conditions and systematic comorbidities. Additionally, patients with differences that could cause bias between the sides were excluded from the study.
The predictor variable is treatment i-PRF or control.
The outcome variables of interest are the pain level and analgesic consumption values on the Visual Analog Scale, the distance between determined reference points, maximum mouth opening, and the Postoperative Symptom Severity scale data. A Postoperative Symptom Severity scale was created using questions commonly employed in the clinical evaluation of patients following the extraction of third molars. This scale was further divided into subscales corresponding to the 7 primary adverse effects identified in a prior study.
Covariate variables, sex, age, and operation times.
The normality of the distribution of the study data was assessed using the Kolmogorov-Smirnov test. Depending on whether the data exhibited a normal distribution or not, the data were analyzed using either the paired t-test or the Wilcoxon test. A P value < .05 was considered statistically significant.
The study included 35 patients with a mean age of 19.97 ± 2.07 years. The i-PRF side significant success in postoperative edema measurements. There was a statistically significant difference observed between the control side and the i-PRF side on the second day (control: 9.74 ± 0.57 mm, i-PRF: 9.46 ± 0.51 mm) and seventh day (control: 9.33 ± 0.59 mm, i-PRF: 9.12 ± 0.50 mm) in lateral canthus-angulus measurements (P: .01 and P: .04, respectively). Additionally, on the second day, there was a statistically significant difference in tragus-commisura measurements (control: 11.53 ± 0.62 mm, i-PRF: 11.31 ± 0.58 mm) with a P value of .02. There was no significant difference observed between the sides in terms of postoperative pain (P > .05). However, analgesic consumption in the i-PRF side was significantly lower at the sixth hour (control: 1.8 ± 0.58 dose, i-PRF: 1.14 ± 0.35 dose), 24th hour (control: 1.77 ± 0.54 dose, i-PRF: 1.14 ± 0.35 dose), and second day (control: 1.8 ± 0.47 dose, i-PRF: 1.4 ± 0.73 dose) postoperatively (P: .000, P: .000, and P: .012). Mouth opening was significantly lower in the i-PRF side on the second day (control: 27.88 ± 6.48 mm, i-PRF: 25.51 ± 5.56 mm) (P: .025). However, i-PRF had no significant effect on postoperative quality of life (P > .05).
According to the study results, i-PRF had a limited effect on the management of postoperative pain, but i-PRF was effective in reducing postoperative edema. Further studies with larger patient sides are now needed to yield more detailed findings on the subject.
Do immediate intramuscular co-administration of diclofenac and dexamethasone or extraoral ice pack application have any influence on pain perception and oral health related quality of life (OHRQoL) following trans-alveolar extraction of impacted mandibular third molars? A comparative study in a Saudi Arabian sub-population
2021, Advances in Oral and Maxillofacial Surgery
Pain perception and QoL are fundamental enquiries patients wants to know regarding trans-alveolar extraction of lower third molar. The current study hopes to compare the influence of co-administration of diclofenac+dexamethasone and icepack on pain and QoL after trans-alveolar surgery of lower third molar. This was a prospective study of patients referred for trans-alveolar extraction of mandibular third molar teeth under local anesthesia. Patients were randomly assigned into Group A (co-administered IM Dexamethasone 8 mg and IM Diclofenac 75 mg in office) and Group B (ice packs extra-orally). Assessment of pain was carried out using the numerical pain rating scale. Validated Arabic version of the 16 item United Kingdom Oral Health Related Quality of Life measure (UK-OHRQoL) was used to evaluate the QoL pre and on the POD's. A total of 78 patients equally distributed into Groups A and B were the study participants. The mean age was 31.6 ± 6.4 years (Group A: 32.5 ± 5.5 and Group B: 30.8 ± 7.2, range 20–48years). The M:F ratio was 1:1.1. Better pain reduction was observed in Group A which became significant (p = 0.019) on POD 3. Domain scores was better in the Group A patients at the body function level (p = 0.016) and personal level (p = 0.013) at POD 1 and body function level (p = 0.044) at POD 3. Overall QoL scores was also better in the Group A with significant difference (p = 0.025) on POD 1. Pain perception, domain and overall QoL scores continues to improves throughout the review period with better improvement in the Group A.
Alveolar Iodine Tampon Packing Reduces Postoperative Morbidity After Third Molar Surgery
2019, Journal of Oral and Maxillofacial Surgery
The aim of this study was to assess the efficacy of an iodine tampon after mandibular third molar surgery on oral health–related quality of life (OHRQoL), use of painkillers, postoperative sequelae, and self-care behaviors in the first postoperative week.
This prospective, crossover, randomized controlled study included patients undergoing surgical removal of bilateral symmetrically, horizontally impacted mandibular third molars. The surgical site was randomly allocated to receive an iodine tampon after surgery or wound closure and rinsing with a Monoject syringe (Tyco/Healthcare-Kendall, Mansfield, MA). The primary outcomes measured each day during the first postoperative week were the Oral Health Impact Profile 14 score and postoperative sequelae, including pain, swelling, limited mouth opening, postoperative infection, and alveolar osteitis. The secondary outcome measures were several self-care behaviors. Data were analyzed using repeated-measures analysis of variance and paired-samples t tests.
A total of 54 patients (25 men and 29 women; mean age, 25.1 years) were enrolled, with a total of 108 surgically removed impacted mandibular third molars. The use of an iodine tampon resulted in a significantly lower impact on OHRQoL (mean of 21.5 [standard deviation (SD), 9.6] vs 26.5 [SD, 10.6]) on the first postoperative day, which was observable until the seventh postoperative day. In addition, after removal of the impacted third molar, patients with the iodine tampon condition reported less pain (mean of 5.2 [SD, 1.9] vs 6.1 [SD, 2.1] on day 1, lasting throughout the week), less use of painkillers, less limited mouth opening, fewer problems chewing, less swelling, and earlier recovery.
The use of postoperative iodine packing after the removal of impacted mandibular third molars significantly reduces OHRQoL and postoperative sequelae.
Efficacy of corticosteroids versus placebo in impacted third molar surgery: systematic review and meta-analysis of randomized controlled trials
2019, International Journal of Oral and Maxillofacial Surgery
The aim of this systematic review was to identify randomized, placebo-controlled clinical trials investigating the effectiveness of corticosteroids in the control of pain, oedema, and trismus following third molar surgery, and to analyse the effects of the type of drug administered and the time and route of drug administration on the outcomes of interest. Searches were performed in the PubMed, Scopus, and Cochrane Library databases. This review was structured according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The search identified 1223 studies. After assessing eligibility based on the inclusion and exclusion criteria, 17 studies were selected for the qualitative analysis (a total of 730 patients aged 15–45 years). Ten studies were included in the meta-analysis, which was performed using Review Manager software. The corticosteroids were effective in controlling pain (P = 0.002; mean difference −17.38, 95% confidence interval −24.81 to −9.95) and trismus (P < 0.00001; mean difference 6.10, 95% confidence interval 3.42 to 8.77). With the exception of the submucosal route, the route of administration did not appear to affect the outcomes. The administration of a corticosteroid in the preoperative phase was superior to its use in the postoperative phase for the control of trismus.
Dexamethasone injection into the pterygomandibular space in lower third molar surgery
2017, International Journal of Oral and Maxillofacial Surgery
This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy).
This article has been retracted at the request of the Authors.
The article duplicates significant parts of a paper that had already appeared in J Dent Anesth Pain Med. 2016 Jun;16(2):95–102. https://doi.org/10.17245/jdapm.2016.16.2.95. One of the conditions of submission of a paper for publication is that authors declare explicitly that the paper has not been previously published and is not under consideration for publication elsewhere. Re-use of any data should be appropriately cited. As such this article represents a misuse of the scientific publishing system. The scientific community takes a very strong view on this matter and apologies are offered to readers of the journal that this was not detected during the submission process.
Effects of co-administered dexamethasone and nimesulide on pain, swelling, and trismus following third molar surgery: a randomized, triple-blind, controlled clinical trial
2017, International Journal of Oral and Maxillofacial Surgery
Citation Excerpt :
A study by Buyukkurt et al. compared the administration of prednisolone alone with the administration of prednisolone + diclofenac and found that the latter combination was more effective with respect to pain, oedema, and postoperative trismus; these authors recommended the use of this combination for surgeries where intense oedema is expected.25 Moore et al. compared the combination of dexamethasone and rofecoxib with dexamethasone alone and also concluded that the previously mentioned combination of drugs is better in several respects.26 Bauer et al. evaluated the efficacy of ibuprofen and dexamethasone combination in patients undergoing surgery for impacted tooth removal.
This study aimed to determine the effect of the co-administration of dexamethasone 8 mg and nimesulide 100 mg given 1 h before mandibular third molar surgery. A prospective, randomized, triple-blind, split-mouth clinical trial was developed at the study institution in Pernambuco, Brazil. A pilot study was first performed (95% confidence interval, 80% test power, and 5% error), and a sample of 40 patients aged between 18 and 40 years was selected. The patients were randomized and divided into two groups: dexamethasone + placebo and dexamethasone + nimesulide. The following parameters were evaluated: pain (visual analogue scale), total number of rescue analgesics taken, time taken to first rescue analgesic consumption, oedema, trismus, and patient satisfaction. The paired t-test and the Wilcoxon test were used to compare means. Statistically significant differences were found between the groups in pain values at 2, 4, and 12 h postoperative, and in the total number of rescue analgesics and time taken to first rescue analgesic ingestion (P < 0.05), with results in favour of dexamethasone + nimesulide administration. Oedema and trismus were similar in the two treatment groups and decreased over time postoperatively. The co-administration of dexamethasone and nimesulide reduces pain intensity and the need for rescue medication after third molar surgery.

View all citing articles on Scopus

Supported in part by an American Association of Oral and Maxillofacial Surgery Student Research Training Award, University of Pittsburgh, and the COXIB Medical Grant Program, Merck & Co Inc.

Presented in part at the American Association for Dental Research/International Association for Dental Research scientific session in New Orleans in 2003.

^∗: As this report was going to press, Merck & Co., Inc. announced a voluntary worldwide withdrawal of rofecoxib (VIOXX®) from the market, due to new study data indicating an increased risk for cardiovascular events, such as heart attack and stroke, following 18 months of treatment. The concept and results of this oral surgery trial confirm the efficacy of intraoperative dexamethasone in managing postoperative trismus and the utility of using the COX-2 inhibitor rofecoxib to limit postoperative pain. Although demonstrated in this clinical trial, the therapeutic strategy of using a nonsteroidal anti-inflammatory agent to prevent postoperative sequellae will require confirmation using alternative selective or nonselective COX inhibitors.

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Preemptive rofecoxib and dexamethasone for prevention of pain and trismus following third molar surgery∗

Objective

Study design

Results

Conclusions

Section snippets

Research design and methods

Results

Discussion

Conclusions

Clin Ther

J Am Dent Assoc

Am J Med

Oral Surg

J Oral Maxillofac Surg

J Oral Maxillofac Surg

Oral Surg Oral Med Oral Pathol

J Oral Maxillofac Surg

Clin Ther

J Am Dent Assoc

J Oral Maxillofac Surg

J Oral Maxillofac Surg

J Oral Maxillofac Surg

J Oral Maxillofac Surg

J Oral Maxillofac Surg

Pain

J Am Dent Assoc

Oral Surg

Management of Acute Postoperative Pain

Bilateral surgical removal of lower third molar teeth as a model for drug evaluation: a test with ibuprofen

Eur J Clin Pharm

The analgesic and anti-inflammatory efficacy of diflunisal and codeine after removal of impacted third molars

Cur Med Res Opin

Preemptive rofecoxib and dexamethasone for prevention of pain and trismus following third molar surgery^∗