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

April 20, 2016 updated by: Manuela Favarin Santin, Federal University of Rio Grande do Sul

Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days
Patients in this group received opioid/ non-opioid analgesic combination.
Other Names:
  • Codeine/ Acetaminophen (Co/Ac)
EXPERIMENTAL: 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.
Drug: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days
Patients in this group received opioid/ non-opioid analgesic combination.
Other Names:
  • Tramadol/ Acetaminophen (Tr/Ac)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 6, 12, 24, 48 and 72 h after first dose administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of additional medication
Time Frame: Up to 72 hours
Registered in the pain diary by the patient.
Up to 72 hours
Adverse reactions reported by patients
Time Frame: Up to 72 hours
Registered in the pain diary by the patient.
Up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (ESTIMATE)

April 25, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12671913.1.0000.5347

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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