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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Periapical Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Patients in this group received opioid/ non-opioid analgesic combination.

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Patients in this group received opioid/ non-opioid analgesic combination.

Interventions

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

Patients in this group received opioid/ non-opioid analgesic combination.

Intervention Type DRUG

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

Patients in this group received opioid/ non-opioid analgesic combination.

Intervention Type DRUG

Other Intervention Names

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Codeine/ Acetaminophen (Co/Ac) Tramadol/ Acetaminophen (Tr/Ac)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No