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

Primary Purpose

Periapical Abscess

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days
Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Abscess focused on measuring Acetaminophen, Analgesia, Codeine, Drug Combinations, Endodontics, Periapical abscess, Randomized Controlled Trial, Tramadol, Visual analog scale

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Co/ Ac

    Tr/ Ac

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Reduction of pain scores over time.
    Pain scores were obtained using VAS before and after the first appointment.

    Secondary Outcome Measures

    Frequency of additional medication
    Registered in the pain diary by the patient.
    Adverse reactions reported by patients
    Registered in the pain diary by the patient.

    Full Information

    First Posted
    April 15, 2016
    Last Updated
    April 20, 2016
    Sponsor
    Federal University of Rio Grande do Sul
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02750696
    Brief Title
    Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess
    Official Title
    Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Rio Grande do Sul
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periapical Abscess
    Keywords
    Acetaminophen, Analgesia, Codeine, Drug Combinations, Endodontics, Periapical abscess, Randomized Controlled Trial, Tramadol, Visual analog scale

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Co/ Ac
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Tr/ Ac
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days
    Other Intervention Name(s)
    Codeine/ Acetaminophen (Co/Ac)
    Intervention Description
    Patients in this group received opioid/ non-opioid analgesic combination.
    Intervention Type
    Drug
    Intervention Name(s)
    Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days
    Other Intervention Name(s)
    Tramadol/ Acetaminophen (Tr/Ac)
    Intervention Description
    Patients in this group received opioid/ non-opioid analgesic combination.
    Primary Outcome Measure Information:
    Title
    Reduction of pain scores over time.
    Description
    Pain scores were obtained using VAS before and after the first appointment.
    Time Frame
    0, 6, 12, 24, 48 and 72 h after first dose administration
    Secondary Outcome Measure Information:
    Title
    Frequency of additional medication
    Description
    Registered in the pain diary by the patient.
    Time Frame
    Up to 72 hours
    Title
    Adverse reactions reported by patients
    Description
    Registered in the pain diary by the patient.
    Time Frame
    Up to 72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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

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