Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Bethametasone; Drug: Placebo

• Registration Number: NCT02865746
• Lead Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-05
• Study Completion: 2005-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-11
• Last Update Submitted: 2016-08-11
• Study First Posted: 2016-08-12
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group betamethasone	Bethametasone	Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg
Group placebo	Placebo	sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg

Primary Outcome Measures

Name	Time	Method
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"	48 hours after treatment	During the post-surgical interval of 48 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"

Secondary Outcome Measures

Name	Time	Method
Analgesic consumption	48 hours after treatment	Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.

Trial Locations

Locations (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri; 🇧🇷 Diamantina, Minas Gerais, Brazil