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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02750696

Enrollment

Registered

2016-04-25

Start date

2013-04-30

Completion date

2015-04-30

Last updated

2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Abscess

Keywords

Acetaminophen, Analgesia, Codeine, Drug Combinations, Endodontics, Periapical abscess, Randomized Controlled Trial, Tramadol, Visual analog scale

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.

Interventions

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

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction of pain scores over time.	0, 6, 12, 24, 48 and 72 h after first dose administration	Pain scores were obtained using VAS before and after the first appointment.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026