Clinical trial NCT02865746: Betamethasone to Control Postoperative Pain in Emergency Endodontic Care
Official title: Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Steroids
Pain measurement
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
First posted: 2016-08-12
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 72
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
timeFrame: 4 hours after treatment
measure: Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
timeFrame: 24 hours after treatment
measure: Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
timeFrame: 48 hours after treatment
Secondary outcomes:
measure: Analgesic consumption
timeFrame: 4 hours after treatment
measure: Analgesic consumption
timeFrame: 24 hours after treatment
measure: Analgesic consumption
timeFrame: 48 hours after treatment
Other outcomes:
Locations:
city: Diamantina
country: Brazil
facility: Universidade Federal dos Vales do Jequitinhonha e Mucuri
state: Minas Gerais
Study officials:
affiliation: Federal University of Valleys of Jequitinhonha and Mucuri
name: Marcos P. Pinheiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: