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

Study Overview
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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.

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

Conditions
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Periapical Abscess

Intervention / Treatment
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* Drug: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days
* Drug: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Co/ Ac<br>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<br>* Patients in this group received opioid/ non-opioid analgesic combination.<br>* Other names: Codeine/ Acetaminophen (Co/Ac);|
| Experimental: Tr/ Ac<br>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<br>* Patients in this group received opioid/ non-opioid analgesic combination.<br>* Other names: Tramadol/ Acetaminophen (Tr/Ac);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain scores over time. | 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 | Registered in the pain diary by the patient. | Up to 72 hours | 
| Adverse reactions reported by patients | Registered in the pain diary by the patient. | Up to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Analgesia, Codeine, Drug Combinations, Endodontics, Periapical abscess, Randomized Controlled Trial, Tramadol, Visual analog scale