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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2014

Interventions

  • Drug: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days
    • Patients in this group received opioid/ non-opioid analgesic combination.
  • Drug: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days
    • Patients in this group received opioid/ non-opioid analgesic combination.

Arms, Groups and Cohorts

  • Active Comparator: Co/ Ac
    • Codeine/acetaminophen (30 mg/500 mg) analgesic association tablets. Patients in this group received one fixed-dose oral tablet of codeine/acetaminophen (30 mg/500 mg) every 4 hours for 3 days.
  • Experimental: Tr/ Ac
    • Tramadol/acetaminophen (37.5 mg/325 mg) analgesic association tablets. Patients in this group received one fixed-dose oral tablet of tramadol/acetaminophen (37.5 mg/325 mg) every 4 hours for 3 days.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of Acute Periradicular Abscess – Age greater than 18 years – Spontaneous pain greater than 40 mm measured in Visual Analogue Scale (moderate to severe pain). Exclusion Criteria:

  • Intake of analgesics or antibiotics within 4 hours prior to emergency surgery – Allergy to the drugs used in this study – Gastric ulcer, liver or kidney disease – Uncontrolled diabetes mellitus or epilepsy – Pregnancy or lactation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Rio Grande do Sul
  • Collaborator
    • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Manuela Favarin Santin, PhD – Federal University of Rio Grande do Sul

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