Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

Overview

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.

Full Title of Study: “Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care – A Randomized Double Blind Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2005

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.

Interventions

  • 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.
  • Drug: 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Pain determined using the “Point Verbal Rating Scale – Modified VRS4″
    • Time Frame: 4 hours after treatment
    • During the post-surgical interval of 4 hours, the pain was determined using the “Point Verbal Rating Scale – Modified VRS4″
  • Pain determined using the “Point Verbal Rating Scale – Modified VRS4″
    • Time Frame: 24 hours after treatment
    • During the post-surgical interval of 24 hours, the pain was determined using the “Point Verbal Rating Scale – Modified VRS4″
  • Pain determined using the “Point Verbal Rating Scale – Modified VRS4″
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 72 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federal University of the Valleys of Jequitinhonha and Mucuri
  • Collaborator
    • University of Campinas, Brazil
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marcos P. Pinheiro, PhD, Principal Investigator, Federal University of Valleys of Jequitinhonha and Mucuri

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