Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days
- Conditions
- Periapical Abscess
- Sponsor
- Federal University of Rio Grande do Sul
- Enrollment
- 27
- Primary Endpoint
- Reduction of pain scores over time.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Manuela Favarin Santin
PhD
Federal University of Rio Grande do Sul
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days
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.
Intervention: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days
Outcomes
Primary Outcomes
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 Outcomes
- Frequency of additional medication(Up to 72 hours)
- Adverse reactions reported by patients(Up to 72 hours)