Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

Study Overview
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Brief Summary
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The objective of this randomized double-blind study was to evaluate the effect of betamethasone in the control of postoperative pain in patients undergoing endodontic treatment.

Detailed Description
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To prevent post endodontic treatment pain, systemic administration of corticosteroids may have their effect maximized if the infiltration is performed in the oral mucosa, near the periapex of the tooth, which concentrates the inflammatory process. The administration of corticosteroids at this moment, taking advantage of the anesthetic effect still present, ensures continuous comfort during the postoperative period. The objective of this randomized double-blind clinical trial was to evaluate the effect of the systemic administration of betamethasone - through infiltration in the oral mucosa - to control pain and edemas in patients undergoing emergency endodontic treatment.

Official Title
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Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Bethametasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals had to have a tooth with pain of endodontic origin justifying emergency care; Individuals diagnosed with irreversible pulpitis or necrosis associated to pericementitis. Exclusion Criteria: Individuals who presented: Pregnancy or lactation; Use of corticosteroids; History of hypersensitivity to the drugs used in this study; Pain associated with abscesses of endodontic origin; Individuals with tuberculosis; Individuals with systemic fungal infections; Individuals with simple ocular herpes; Individuals with glaucoma; Individuals with acute psychosis. Individuals with psychotic tendencies.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group betamethasone<br>Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg | Drug: Bethametasone<br>* The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.<br>* Other names: Group 1;|
| Placebo Comparator: Group placebo<br>sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg | Drug: Placebo<br>* The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.<br>* Other names: Group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain determined using the Point Verbal Rating Scale - Modified VRS4 | During the post-surgical interval of 4 hours, the pain was determined using the Point Verbal Rating Scale - Modified VRS4 | 4 hours after treatment | 
| Pain determined using the Point Verbal Rating Scale - Modified VRS4 | During the post-surgical interval of 24 hours, the pain was determined using the Point Verbal Rating Scale - Modified VRS4 | 24 hours after treatment | 
| Pain determined using the Point Verbal Rating Scale - Modified VRS4 | During the post-surgical interval of 48 hours, the pain was determined using the Point Verbal Rating Scale - Modified VRS4 | 48 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption | Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more. | 4 hours after treatment | 
| Analgesic consumption | Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more. | 24 hours after treatment | 
| Analgesic consumption | Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more. | 48 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Steroids, Pain measurement