Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

NCT02865746 | Completed DMC

• 1 other identifier: ufvjm
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Steroids; Pain measurement

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Analgesic consumption

  4 hours after treatment

• Analgesic consumption

  24 hours after treatment

• Analgesic consumption

  48 hours after treatment

Study Arms (2)

Group betamethasone

ACTIVE COMPARATOR

Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg

Drug: Bethametasone

Group placebo

PLACEBO COMPARATOR

sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg

Drug: Placebo

Interventions

Bethametasone DRUG

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.

Also known as: Group 1

Group betamethasone

Placebo DRUG

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.

Also known as: Group 2

Group placebo

Eligibility Criteria

• Age: 10 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals had to have a tooth with pain of endodontic origin justifying emergency care;
• Individuals diagnosed with irreversible pulpitis or necrosis associated to pericementitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead
• University of Campinas, Brazil: collaborator

Study Sites (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcos P. Pinheiro, PhD

  Federal University of Valleys of Jequitinhonha and Mucuri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 12, 2016
• Study Start: July 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

BR (1)