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

Not Applicable

Completed

• Conditions: Periapical Abscess
• Interventions: 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

• Registration Number: NCT02750696
• Lead Sponsor: Federal University of Rio Grande do Sul

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 Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2014-12
• Study Completion: 2015-04
• Status Verified: 2016-04
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-25
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tr/ Ac	Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days	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.
Co/ Ac	Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days	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.

Primary Outcome Measures

Name	Time	Method
Reduction of pain scores over time.	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 Outcome Measures

Name	Time	Method
Frequency of additional medication	Up to 72 hours	Registered in the pain diary by the patient.
Adverse reactions reported by patients	Up to 72 hours	Registered in the pain diary by the patient.