Clinical Trial: Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial

Brief Summary:

Aim: The aim of this study was to compare the analgesic efficacy of two combinations of opioid and non-opioid analgesics for acute periradicular abscesses.

Methodology: This study included 24 patients who sought emergency care in a Brazilian dental school. The patients were randomly divided into two groups: Codeine/Acetaminophen - oral prescription of codeine (30 mg) plus acetaminophen (500 mg), every 4 h, for 3 days or Tramadol/Acetaminophen - oral prescription of tramadol hydrochloride (37.5 mg) plus acetaminophen (500 mg) on the same schedule. Patients recorded pain scores in a pain diary 6, 12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale.


Detailed Summary:
Sponsor: Federal University of Rio Grande do Sul

Current Primary Outcome: Reduction of pain scores over time. [ Time Frame: 0, 6, 12, 24, 48 and 72 h after first dose administration ]

Pain scores were obtained using VAS before and after the first appointment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Frequency of additional medication [ Time Frame: Up to 72 hours ]
    Registered in the pain diary by the patient.
  • Adverse reactions reported by patients [ Time Frame: Up to 72 hours ]
    Registered in the pain diary by the patient.


Original Secondary Outcome: Same as current

Information By: Federal University of Rio Grande do Sul

Dates:
Date Received: April 15, 2016
Date Started: April 2013
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016