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

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ClinicalTrials.gov Identifier: NCT02750696
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Manuela Favarin Santin, Federal University of Rio Grande do Sul

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.


Condition or disease Intervention/treatment Phase
Periapical Abscess 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Active Comparator: Co/ Ac
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
Patients in this group received opioid/ non-opioid analgesic combination.
Other Name: Codeine/ Acetaminophen (Co/Ac)

Experimental: Tr/ Ac
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
Patients in this group received opioid/ non-opioid analgesic combination.
Other Name: Tramadol/ Acetaminophen (Tr/Ac)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Frequency of additional medication [ Time Frame: Up to 72 hours ]
    Registered in the pain diary by the patient.

  2. Adverse reactions reported by patients [ Time Frame: Up to 72 hours ]
    Registered in the pain diary by the patient.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Manuela Favarin Santin, PhD, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02750696     History of Changes
Other Study ID Numbers: 12671913.1.0000.5347
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

Keywords provided by Manuela Favarin Santin, Federal University of Rio Grande do Sul:
Acetaminophen
Analgesia
Codeine
Drug Combinations
Endodontics
Periapical abscess
Randomized Controlled Trial
Tramadol
Visual analog scale

Additional relevant MeSH terms:
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Abscess
Periapical Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Periapical Periodontitis
Periapical Diseases
Jaw Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases
Periodontitis
Acetaminophen
Analgesics, Opioid
Tramadol
Codeine
Analgesics, Non-Narcotic
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Antitussive Agents
Respiratory System Agents