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
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
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
NCT ID
NCT02750696
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.
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
Learn more about this trial
Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess
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