Pre-Emptive Effect of Dexamethasone and Diclofenac Sodium Associated With Codeine on Pain, Swelling, and Trismus After Third Molar Surgery: A Split-Mouth, Randomized, Triple-Blind, Controlled Clinical Trial

doi:10.1016/j.joms.2017.06.012

Journal of Oral and Maxillofacial Surgery

Volume 76, Issue 1, January 2018, Pages 60-66

https://doi.org/10.1016/j.joms.2017.06.012 Get rights and content

Purpose

We aimed to compare the effect of dexamethasone, 8 mg, and diclofenac sodium, 50 mg, associated with codeine, 50 mg, on the control of pain, swelling, and trismus after extraction of impacted third molars.

Materials and Methods

Fifteen healthy patients with a mean age of 22.8 years (SD, 12.62 years) received a single oral dose of either drug 1 hour before each surgical procedure (left and right teeth). At 24, 48, and 72 hours after surgery, swelling was determined by use of linear measurements on the face and trismus was determined by maximal mouth opening. Postoperative pain was self-recorded by the patients using a numerical rating scale at 24-hour intervals for a period of 72 hours. Data analysis involved descriptive statistics and Shapiro-Wilk, Wilcoxon, and paired t tests (P < .05).

Results

Dexamethasone controlled pain (P = .016) and edema (P = .08) within 48 hours better than diclofenac sodium associated with codeine. No statistically significant differences were found between drugs regarding trismus and consumption of rescue analgesics (acetaminophen).

Conclusions

The results of this study suggest that pre-emptive administration of dexamethasone, 8 mg, showed better control of pain and swelling in bilateral extractions of third impacted mandibular molars.

Section snippets

Study Design

A controlled, triple-blind clinical trial was performed. This study was randomized, and a split-mouth design was conducted. Because this study had a split-mouth design, each included patient served as his or her own control. There was no placebo group so that the gold-standard treatment was offered to the patients enrolled in this study. The study protocol complied with the guidelines of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials.¹⁷ It was approved by the

Results

Of the 16 patients selected, 1 underwent only 1 surgical extraction, because of personal issues, and was excluded from this study. Thus 15 patients (3 men and 12 women; mean age, 22.8 years; SD, 2.62 years) participated in all stages of the study (Fig 1). There was 1 case of transient paresthesia of the lingual nerve that resolved spontaneously, and there were no reports of adverse reactions to the drugs used in this study.

No statistically significant differences between groups were found

Discussion

Controlling postoperative pain is a major challenge for surgical practice in dentistry, and there has been a constant search for pharmacologic protocols that minimize complications caused by invasive procedures.²¹ Drugs used in multimodal analgesia—a regimen that captures the effectiveness of individual agents in optimal dosages that maximize efficacy and attempts to minimize side effects from one analgesic (mainly opioids)—should belong to different classes, with different mechanisms of

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Cited by (33)

Variations in reporting of clinician-reported outcome measures in third molar surgery: A focused review
2022, Surgeon
Citation Excerpt :
Swelling and mouth opening/trismus were the most commonly reported ClinRO measures (16/20), followed by soft tissue healing (4/20), bone regeneration (3/20) and alveolar osteitis and periodontal probing depth (2/20). Three studies reported one patient with paraesthesia,12–14 with the remaining 17 studies making no specific reference to nerve injury. Two or more ClinRO measures were reported in all but one RCT.
Clinician-reported outcome measures (ClinRO measures) play a fundamental role in quality assurance throughout healthcare systems. With commissioners turning ever more frequently to ClinRO data to evaluate and compare individual hospital performance and casemix, and funding decisions increasingly relying on these data, agreed core outcome sets (COS) are essential for the collection of standardised specialty-specific outcomes. Beyond their role in service commissioning, COS enable standardisation of outcomes in clinical studies, allowing comparisons to be drawn between similar trials as well as pooling of data for systematic reviews and metaanalyses. This review explores those ClinRO measures most commonly reported in the third molar literature, highlighting inconsistencies in ClinRO selection, measurement and reporting among researchers. We recognise here a prime opportunity for the specialty to address this lag in COS relative to other surgical specialties. With the Quality Outcomes in Maxillofacial Surgery (QOMS) overseeing the institution of many subspecialty-specific national databases in recent years, OMFS is well placed to develop a series of COS for each subspecialty domain for the benefit of researchers, clinicians and ultimately, patients.
Postoperative pain and edema control following different protocols of preemptive analgesia in the surgical removal of impacted third molars: A triple-blind parallel randomized placebo-controlled clinical trial
2021, Journal of Cranio-Maxillofacial Surgery
Citation Excerpt :
The preemptive analgesia with ibuprofen was also determined to be insufficient to produce clinical significant results when compared to placebo, whereas its association with dexamethasone provide better postoperative pain control and less consumption of rescue medication (Bauer et al., 2013). It has been advocated that dexamethasone is the drug of choice for preemptive analgesia in the surgical removal of third molars (Lima et al., 2018) since different clinical trials have confirmed its effectiveness in reducing pain and edema. It was also stated that, as a potent anti-inflammatory agent, it has an effective pain and edema reduction distinguished from the routes of administration, dosage and timing (Shoohanizad and Parvin, 2020).
This randomized controlled clinical trial aimed to evaluate the preemptive effects of acetaminophen, ibuprofen, ketoprofen, nimesulide or dexamethasone on postoperative pain and edema in the surgical removal of impacted third molars.
Participants underwent bilateral surgeries at 2 different times and were randomly given the test drug or placebo (split-mouth). Postoperative pain, edema and rescue medication were evaluated at different times. Study power was >80% for the observed effect size in the crossover repeated measures design. Differences between test drug and placebo were the response variable. Generalized Estimation Equation models were adjusted for each outcome.
Sample comprised 5 groups (n = 20 each). Ibuprofen and nimesulide showed higher overall effects on pain scores over time, with no differences between them (p = 0.557). Acetaminophen showed significantly lower overall effects in edema control over time, when compared to other test drugs, that showed similar effects. Lower quantity of rescue medication were also observed for ibuprofen and nimesulide, with no differences between them (p = 0.999). Ibuprofen and nimesulide showed beneficial overall preemptive effects. Hence, in the decision-making process for preemptive analgesia in impacted third molar surgeries, ibuprofen and nimesulide should be considered on a case-by-case basis as the drugs of choice.
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.
Do Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy Minimize Postoperative Pain and Edema After Molar Extraction?
2020, Journal of Oral and Maxillofacial Surgery
This study was designed to examine the efficacy of antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT) in reducing postoperative pain and edema after molar extractions.
The investigators designed a single-blind randomized controlled study and enrolled subjects requiring extraction of at least one of the first or second molars. They were randomized to one of the following four groups: control group, aPDT group, LLLT group, and aPDT and LLLT group. Patients were blinded to the group assigned. The outcome variables were postoperative pain and edema. Pain intensity was measured on a visual analog scale (recorded every day for 7 days after tooth extraction). Facial edema was assessed by measuring the perimeter between the tragus, base of the jaw, and labial commissure, which was recorded once before surgery and then on the third and seventh days after surgery. Other variables were age, sex, ethnicity, decayed/missing/filled teeth, and tooth types. Appropriate univariate and bivariate statistics were computed and statistical significance was set at a value of P < .05.
The sample was composed of 40 patients with a mean age of 41.25 ± 13.97 years and 25 (62.5%) of them were women. There were 10 subjects in each treatment group. The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05). Postoperative pain was lowest in the aPDT + LLLT group in the 1st, 2nd, 3rd, 5th, 6th, and 7th day after tooth extraction (P < .05). There were no significant differences in edema among the groups (P > .05).
The combined use of aPDT and LLLT was effective in reducing postoperative pain. These procedures can be applied in everyday surgical practice.
The Effectiveness of Hyaluronic Acid in Controlling Pain, Edema, and Trismus After Extraction of Third Molars: Systematic Review and Meta-Analysis
2020, Journal of Oral and Maxillofacial Surgery
This study aimed to evaluate the clinical evidence of hyaluronic acid (HA) in minimizing inflammatory parameters such as pain, edema, and trismus after extraction of third molar (3M). An electronic search was conducted in 4 databases. The eligibility criteria included clinical trials that used HA compared with placebo or no treatment after 3M surgeries. The search strategy resulted in 752 references, of which 5 studies were included comprising 271 patients. Regarding the risk of bias analysis, most criteria were rated as low or unclear risk of bias. All the evaluated studies were classified as low risk of bias in the selective reporting criteria. The final quantitative analysis of the variables showed that the use of HA resulted in a greater reduction of pain levels on the third (mean difference = −0.68; 95% confidence interval, −1.20 to −0.17) and seventh (mean difference = −0.36; 95% confidence interval, −0.64 to −0.09) postoperative days. There are no differences between the analyzed groups in relation to trismus. It was not possible to conduct meta-analysis for the edema variable because of the heterogeneity of the methods of measurement. The results suggest that HA seems to provide a lower average pain on the third and seventh postoperative days and has no influence on postoperative trismus after extraction of 3Ms; however, more research with stronger methodology is needed to determine its efficacy.
Envelope or triangular flap for surgical removal of third molars? A systematic review and meta-analysis
2020, International Journal of Oral and Maxillofacial Surgery
Citation Excerpt :
Also, the standardization of the surgical techniques such as osteotomy, tooth sectioning, irrigation, suture technique, drug protocol, and a detailed description of the flap design used should be provided. These eligibility criteria and methodological rigor can be verified in some recent clinical trials that have evaluated the efficacy of alternative medications and treatments to control postoperative complications in third molar surgeries7,53,54. These aspects would make the results more reliable to indicate the surgical flap design to be chosen.
The aim of this systematic review was to compare the triangular and envelope flaps in mandibular third molar surgery with regard to pain, oedema, and trismus. Secondary outcomes assessed were dehiscence, ecchymosis, alveolar osteitis, periodontal condition, and surgical time. The PRISMA guidelines and recommendations in the Cochrane Handbook were followed, and the review was registered before commencement (PROSPERO; CRD42018112373). The literature search was conducted in the Web of Science, PubMed, Virtual Health Library, Cochrane Library, and Scopus databases and in the grey literature; randomized clinical trials, indexed through November 2018 were included. Three reviewers independently examined the studies. Twenty studies were included in the qualitative analysis, of which 18 were included in the meta-analyses. The flap design did not influence pain, oedema, trismus, dehiscence, or osteitis. The triangular flap was associated with a greater occurrence of postoperative ecchymosis (odds ratio 4.58, 95% confidence interval 1.34 to 15.91, I² = 0) and lower periodontal probing depth on day 7 postoperative (standardized mean difference −1.36, 95% confidence interval −2.68 to −0.03, I² = 88%) when compared to the envelope flap in mandibular third molar surgeries.

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: Financial support was provided by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES), Brazil.

: Conflict of Interest Disclosures: None of the authors have any relevant financial relationship(s) with a commercial interest.

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Anesthesia/facial painPre-Emptive Effect of Dexamethasone and Diclofenac Sodium Associated With Codeine on Pain, Swelling, and Trismus After Third Molar Surgery: A Split-Mouth, Randomized, Triple-Blind, Controlled Clinical Trial

Purpose

Materials and Methods

Results

Conclusions

Section snippets

Study Design

Results

Discussion

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

Int J Oral Maxillofac Surg

J Oral Maxillofac Surg

Int J Oral Maxillofac Surg

Oral Surg Oral Med Oral Pathol

Oral Maxillofac Surg Clin North Am

J Oral Biol Craniofac Res

J Craniomaxillofac Surg

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

J Oral Maxillofac Surg

Pain

The use of methylprednisolone versus diclofenac in the treatment of inflammation and trismus after surgical removal of lower third molars

Med Oral Patol Oral Cir Bucal

Does the preemptive use of oral nonsteroidal anti-inflammatory drugs reduce postoperative pain in surgical removal of third molars? A meta-analysis of randomized clinical trials

Anesth Prog

Clinical comparative study of the effectiveness of two dosages of Dexamethasone to control postoperative swelling, trismus and pain after the surgical extraction of mandibular impacted third molars

Med Oral Patol Oral Cir Bucal

Relative efficacy of oral analgesics after third molar extraction—A 2011 update

Br Dent J

Anesthesia/facial pain
Pre-Emptive Effect of Dexamethasone and Diclofenac Sodium Associated With Codeine on Pain, Swelling, and Trismus After Third Molar Surgery: A Split-Mouth, Randomized, Triple-Blind, Controlled Clinical Trial