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

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.

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Key information

Conditions

Periapical Abscess Abscess Agnosia Infections Jaw Diseases Mouth Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Signs and Symptoms Stomatognathic Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Codeine/ Acetaminophen (Co/Ac)

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

Drug

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

Other names: Tramadol/ Acetaminophen (Tr/Ac)

Primary outcomes

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.

Secondary outcomes

Frequency of additional medication

Time frame: Up to 72 hours

Registered in the pain diary by the patient.
Adverse reactions reported by patients

Time frame: Up to 72 hours

Registered in the pain diary by the patient.

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Apr 25, 2016
Registry last updated: Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed