Comparative Study between the Combination of Dexamethasone and Bupivacaine for Third Molar Surgery Postoperative Pain: A Triple-Blind, Randomized Clinical Trial.
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SUBMITTER: Quesada-Bravo FJ
PROVIDER: S-EPMC8584321 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSurgical extraction of the impacted mandibular third molar is commonly associated with postoperative pain, swelling, and trismus. Usually, rotatory instruments like burs have been used for osteotomy, while Piezosurgery is an innovative technique introduced to overcome the weaknesses related to the conventional technique. In addition, Dexamethasone administration before the extraction of impacted third molars is an efficient way to reduce postoperative pain due to robust anti-inflammatory activity. The purpose of the study is to evaluate the effect of piezo-surgery and dexamethasone injection on postoperative sequelae after the surgical extraction of impacted mandibular third molars, and ultimately to compare their effect on reducing postoperative pain.MethodsA randomized controlled clinical trial was conducted with a sample of 80 patients. Participants were divided into four groups: Group 1 (Conventional rotatory), Group 2 (Conventional rotatory with 8 mg dose of dexamethasone 30 min before surgery), Group 3 (Piezo-surgery), and Group 4 (Piezo-surgery with 8 mg dose of dexamethasone 30 min before surgery). The outcome variables were surgical working time calculated in minutes, maximal mouth opening measured in millimeters using Vernier Caliper at baseline and day 3 and postoperative pain assessed using a Visual Analog Scale (VAS) on days 1, 3, and 7.ResultsThe surgical working time was longer in piezo-surgery groups compared with the conventional rotatory instruments groups (15.82 ± 3.47 vs 23.33 ± 2.54; p value < 0.0001). The lowest reduction in mouth opening between baseline and 3rd-day post-op was found in the Piezo-surgery with Dexamethasone group (mean difference = 5.0, SD = 3.9, p value < 0.0001) followed by the Piezosurgery without Dexamethasone group (mean difference = 5.8, SD = 4.5, p value < 0.0001) and the highest average was reported by the Conventional rotatory without Dexamethasone (mean difference = 9.7, SD = 4.5, p value < 0.0001. In the four groups, the mean pain score was highest on the 1st day and gradually decreased over the following days. Comparison of the 1st and 3rd postoperative pain between groups revealed a lowest mean pain score in the Piezo-surgery with Dexamethasone group, followed by Conventional rotatory with Dexamethasone group and a highest mean score in the Conventional rotatory without Dexamethasone group (p value < 0.0001).ConclusionThe association of Piezosurgery osteotomy and Dexamethasone intramuscular injection could be an effective combination to reduce postoperative pain and trismus after impacted third molar surgery.Trial registrationNCT04889781 ( https://clinicaltrials.gov/ ), Date of Registration: 17/05/2021 (retrospectively registered), https://clinicaltrials.gov/ct2/show/NCT04889781?term=NCT04889781&draw=2&rank=1.
| S-EPMC8359387 | biostudies-literature
Project description:The analgesic efficacy and safety of liposomal bupivacaine (LB) in third molar extraction was evaluated in this phase 3, double-blind, placebo-controlled study of subjects undergoing bilateral third molar extraction. Subjects were randomized 2 : 1 to infiltration with LB (133 mg/10 mL) or placebo, and received opioid rescue medication as needed. Primary efficacy measure was cumulative area under the curve (AUC) of numeric rating scale (NRS) pain severity scores through 48 hours (AUC of NRS0-48) postsurgery. Other measures included AUC of NRS0-24, AUC of NRS0-72, and AUC of NRS0-96, and incidence of adverse events. There were 150 subjects in the primary efficacy population (n = 99 LB, n = 51 placebo) and 89 in the per-protocol population (n = 59 LB, n = 30 placebo). Least-squares mean for AUC of NRS0-48 was 172.3 LB versus 194.7 placebo (P = .227) in the primary efficacy population and 120.8 LB versus 183.3 placebo (P = .023) in the per-protocol population. At all time points, between-group differences in AUC of NRS scores were significant in the per-protocol population (LB lower than placebo, P < .05) but not in the primary efficacy population. The adverse event profile was similar between groups. LB produced significantly lower cumulative pain scores versus placebo at all time points in the per-protocol analysis but not in the primary efficacy analysis because of protocol violations. This study indicates significant improvement in pain scores in the third molar model, but because of extensive protocol violations additional studies are warranted to demonstrate effectiveness.
| S-EPMC5579813 | biostudies-literature
Project description:BACKGROUND:This study aimed to evaluate the efficacy of ozonized water on pain, oedema and trismus after impacted third molar mandibular surgeries when compared to double distilled water. A randomized triple blind trial was conducted. METHODS:Patients with third molars class II-B of Pell-Gregory were included, and surgical extraction was performed. Irrigation was done with ozonized (group 1) or double distilled water (group 2). The type of irrigation and the side to be operated were randomized. Neither the patients nor the operator or evaluator were aware of the irrigation solution. Pain, oedema and trismus were evaluated at baseline, 24-h, 48-h, 72-h and 7-days after treatment. The data were evaluated by Friedman, Wilcoxon, Mann-Whitney tests, and size effect. RESULTS:It was included 8 men and 12 women, with a mean age of 20.9y.o. The initial pain mean was 7.94 (±12.81) (group 1) and 5.50 (±9.12) (group 2) (p > 0,05). There was a statistically significant reduction of pain, oedema and trismus in intragroup analysis (p < 0.05). There was no statistically significant difference (p > 0.05) when comparing the oedema and trismus between groups. The size effect ranged from small (0.23) to large (1.29). CONCLUSIONS:It was concluded that ozonized water was compatible as irrigation method, not inferior to double distilled water, and had satisfactory effects on management of pain, oedema and trismus after surgical removal of the third molar. TRIAL REGISTRATION:This clinical trial was registered in ClinicalTrials.gov NCT03501225 on April 18, 2018.
| S-EPMC7003333 | biostudies-literature
Project description:ObjectiveNonsteroidal anti-inflammatory drugs (NSAIDs) are metabolized by the cytochrome P450 enzymes (CYPs), predominantly CYP2C8 and CYP2C9. The aim of this study was to evaluate the possible association of polymorphisms in the CYP2C8*3 and CYP2C9 genes with the clinical efficacy of oral piroxicam (20 mg daily for 4 days) after lower third molar surgeries with regard to postoperative pain, swelling, trismus, adverse reactions, need for rescue medication and the volunteer's overall satisfaction.Materials and methodsFor this purpose, 102 volunteers were genotyped for CYP2C8*3 and CYP2C9 polymorphisms. Briefly, genomic DNA was isolated from saliva collected from volunteers subjected to invasive lower third molar surgeries, and the preoperative, intraoperative and postoperative parameters were collected and analyzed.ResultsAn equal amount of piroxicam sufficiently managed postoperative pain and inflammatory symptoms, with visual analog pain scores typically <40 mm for all genotypes investigated. Furthermore, only two out of 102 volunteers heterozygous for CYP2C8*3 and CYP2C9*3 reported adverse side effects.ConclusionIn general, slow metabolizers of piroxicam, who were volunteers with mutant alleles, were indifferent from normal metabolizers with the wild-type alleles and therefore did not require specialized piroxicam doses to manage postoperative pain and inflammation.
| S-EPMC5505550 | biostudies-literature
Project description:Background:The aim of this randomized, triple-blind trial was to determine the anesthetic, analgesic, and hemodynamic effects of articaine and bupivacaine in the extraction of impacted mandibular third molar teeth. Methods:Twenty-six patients who underwent removal of bilaterally symmetric mandibular third molars were randomly assigned to articaine and bupivacaine groups in a split-mouth design. The onset of anesthetic action, intraoperative comfort, total amount of solution used, duration of postoperative anesthesia and analgesia, rescue analgesic use, postoperative pain, intraoperative bleeding, and hemodynamic parameters were evaluated. Results:In the articaine group, the onset of anesthetic activity was faster, intraoperative comfort was greater, and effective anesthesia required less local anesthetic solution. The bupivacaine group showed a significantly longer duration of postoperative anesthesia and analgesia, in addition to lower visual analog scale values at 6 and 48 hours postoperatively. There were no significant differences between the two solutions regarding rescue analgesic medication use, intraoperative bleeding, or hemodynamics. Conclusion:Articaine showed greater clinical efficacy than bupivacaine in intraoperative anesthesia, achieving faster onset of anesthetic action and greater patient comfort while also requiring less reinforcement during surgery. However, bupivacaine was superior in terms of postoperative anesthesia, reducing postoperative pain due to its residual anesthetic and analgesic effects. Both anesthetic solutions led to similar hemodynamics at low doses in mandibular third molar surgery.
| S-EPMC8637915 | biostudies-literature
Project description:ObjectiveEvaluate the effectiveness of LLL (Low level laser therapy) in auriculotherapy points for pain reduction following lower third molar extractions.Study designRandomized, controlled, single-blinded study.MethodsEighty-four bilateral, symmetrical third molar surgeries were performed in 42 healthy patients using a split-mouth design. In the immediate postoperative period, each side was randomly treated in a single-blind method with an LLL at the auriculotherapy points or simulation of its use (contralateral side) over a 21-day interval. This protocol was repeated 24 and 48 hours after surgery. All patients used the same analgesic (paracetamol) but only in case of pain. The primary variable was postoperative pain according to the visual analogue scale, and the secondary variables were mouth opening, edema, local temperature, dysphagia, and the presence of infection (systemic temperature, lymphadenopathy). These variables were evaluated at baseline and at 24 hours, 48 hours and seven days after surgery. Adverse effects were recorded and reported.ResultsThere was no difference between the groups in relation to any of the evaluated parameters (p>0.05).ConclusionFor this experimental model, application of a low-intensity laser at auriculotherapy points did not prevent postoperative pain following lower third molar surgery.Trial registrationThis trial is registered at ClinicalTrials.gov; the registration number is NCT02657174 and the Unique Protocol ID number is 1.100.869. (https://register.clinicaltrials.gov/prs/app/template/EditRecord.vm?epmode=View&listmode=Edit&uid=U0002BEY&ts=11&sid=S0006026&cx=6g4wff).
| S-EPMC6007895 | biostudies-literature
Project description:BackgroundA comfortable postoperative return to daily activities has increased the need to control inflammation after third molar surgery. Anti-inflammatory drugs and analgesics are not exempt from adverse effects such as allergies and chronic gastritis, and they are not without cost. The association between low-level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated. Among its advantages, we can mention the low risk of side effects, low cost and simplicity of application. The objective of this study is to evaluate the efficiency of low-level laser at auriculotherapy points in reducing postoperative pain in lower third molar surgery.Methods/designNinety bilateral, symmetrical lower third molar surgeries will be performed in 45 healthy patients. Each patient will be their own control, through a split-mouth crossover study. One side of the mouth will be randomly chosen and, immediately after surgery, will be treated with low-level laser. After 21 days, the contralateral side will be operated on with low-level laser simulation used postoperatively. This regimen (laser application or not) will be repeated at 24 and 48 h after surgery. All patients will be requested to take analgesics (acetaminophen) if they have pain, i.e. in case of pain. Neither the surgeon nor the patients will know the assigned treatment. The primary variable will be postoperative pain assessed using a Visual Analog Scale, and the secondary variables will be trismus, edema, local temperature, dysphagia, presence of infection and painkiller ingestion. These variables will be assessed at baseline, 24 h, 48 h and 7 days after surgery. Blood samples for systemic inflammatory cytokine (TNF-α, IL-1, IL-6 and IL-8) analysis will be assessed at baseline and 24 h after surgery.DiscussionSome authors believe that using a wavelength of 633 to 670 nm is a good option for laser therapy in the field of acupuncture. This wavelength can penetrate biological tissue to a depth of about 3 mm. However, for auriculotherapy points, the stimulus (mustard seeds, needles 1 to 2.5 mm) does not penetrate so deeply. For this reason, we chose a laser wavelength of 660 nm (red wavelength).Trial registrationClinicalTrials.gov Identifier: NCT02657174 , registered on 11 January 2016.
| S-EPMC5010672 | biostudies-literature
Project description:Objectives. The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute postoperative pain after the surgical removal of an impacted mandibular third molar. Materials and Methods. The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets. Results. The pain intensity score on the first day was significantly lower in the analgesic group than in the placebo group (p < 0.001). The time to using rescue therapy was significantly longer in the analgesic group than in the placebo group (p = 0.004). The number of paracetamol-codeine tablets used postoperatively did not differ between the analgesic and placebo groups (p = 0.104). Conclusions. Preoperative paracetamol-codeine is effective in providing immediate postoperative pain control after third molar surgery and in delaying the initial onset of pain. This trial is registered with ClinicalTrials.gov Identifier (Registration Number): NCT03049878.
| S-EPMC5343255 | biostudies-literature
Project description:Background: To analyze the pain modulation capacity profile in a Brazilian population, the relationship between opioid receptor (OPRM1) and Catechol-O-methyltransferase (COMT) 1polymorphisms and pain modulation capacity was determined through preoperative pain modulation tests and acute postoperative pain control evaluation, swelling, and trismus in 200 volunteers undergoing lower third molar removal. Methods: Psychologic and clinical parameters were measured. Patient DNA was sequenced for single nucleotide polymorphisms in OPRM1 and COMT, and the salivary concentration of interleukin (IL)-2 (IL)-6, interferon (IFN)-γ and tumor necrosis factor (TNF)-α was evaluated. Primary outcomes were the influence of all predictors on the fluctuation of pain intensity using a visual analogue scale (VAS), and swelling and trismus on the 2nd and 7th postoperative days. Preoperative pain modulation capacity (CPM), pain catastrophizing scale (PCS), body mass index (BMI), and surgery duration and difficulty were evaluated. Results: Salivary concentration of IFN-γ and IL-2 as well as the duration of surgery influenced the fluctuation of postoperative pain in the VAS, and in the sum of the differences in pain intensity test at 8, 48, and 96 h. BMI influenced swelling, while both BMI and COMT haplotype influenced trismus on the 2nd postoperative day. Conclusion: Polymorphisms in COMT, salivary concentrations of IL-2 and IFN-γ, BMI, and duration of surgery were predictors for pain fluctuation, swelling, and trismus on the 2nd day after lower third molar extraction. This therapy was effective in controlling inflammatory symptomatology after lower third molar extraction and ibuprofen was well tolerated by patients. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03169127.
| S-EPMC8082138 | biostudies-literature
Project description:Background and objectivesThe combination of clonidine with local anesthetic administered for epidural anesthesia via caudal route seems to improve the quality of postoperative analgesia, but with conflicting results. This study compared the postoperative analgesia of three different doses of clonidine combined with bupivacaine in caudal epidural anesthesia in children undergoing hypospadias repair.MethodsEighty children aged 1 to 10 years, candidates for surgical repair of hypospadias, were randomly divided into four groups of 20 patients to receive general anesthesia combined with caudal epidural anesthesia with bupivacaine 0.165% alone or in combination with 1, 2 or 3μg.kg-1 of clonidine. The primary outcome was morphine consumption in the first 24hours postoperatively. Mean arterial pressure, heart rate, end-tidal concentration of sevoflurane, time to awakening, pain severity (FLACC scale), level of sedation (RAMSAY), duration of analgesia, and occurrence of adverse effects were also compared.ResultsIntraoperatively, there was no difference between groups regarding mean arterial pressure, heart rate, end-tidal concentration of sevoflurane, and time to awakening. Postoperative morphine consumption and pain severity were similar between groups, but the group receiving clonidine (3μg.kg-1) had lower heart rate and higher sedation level than the group receiving bupivacaine alone.ConclusionsThe combination of clonidine at doses of 1, 2 or 3μg.kg-1 with bupivacaine 0.16% via caudal epidural route did not alter the consumption of morphine in the early postoperative period of children undergoing hypospadias repair.
| S-EPMC9391797 | biostudies-literature