Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865746
• Other study ID #: ufvjm
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 11, 2016
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: August 2016
• Source: Federal University of the Valleys of Jequitinhonha and Mucuri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 72 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Pain
• Pain, Postoperative

Intervention

Drug:
• Bethametasone
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.
• Placebo
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.

Locations

Country	Name	City	State
Brazil	Universidade Federal dos Vales do Jequitinhonha e Mucuri	Diamantina	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri	University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No