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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

Tracking Information
First Submitted Date  ICMJE April 15, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date April 25, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess
Official Title  ICMJE Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Periapical Abscess
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days
  • 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.
    Intervention: Drug: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2016)
27
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02750696
Other Study ID Numbers  ICMJE 12671913.1.0000.5347
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manuela Favarin Santin, Federal University of Rio Grande do Sul
Study Sponsor  ICMJE Federal University of Rio Grande do Sul
Collaborators  ICMJE Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators  ICMJE Not Provided
PRS Account Federal University of Rio Grande do Sul
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP