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

Federal University of Rio Grande do Sul

Status: Completed

Conditions: Periapical Abscess

Treatments: Drug: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days; Drug: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days

Study type: Interventional

Funder types: Other

Identifiers

NCT02750696

12671913.1.0000.5347

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups

Co/ Ac

Active Comparator group

Description:

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.

Treatment:

Drug: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days

Tr/ Ac

Experimental group

Description:

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.

Treatment:

Drug: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days