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

F

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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