NCT02750696

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

April 15, 2016

Last Update Submit

April 20, 2016

Conditions

Periapical Abscess

Keywords

AcetaminophenAnalgesiaCodeineDrug CombinationsEndodonticsPeriapical abscessRandomized Controlled TrialTramadolVisual analog scale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Frequency of additional medication

    Up to 72 hours

  • Adverse reactions reported by patients

    Up to 72 hours

Study Arms (2)

Co/ Ac

ACTIVE COMPARATOR

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

Tr/ Ac

EXPERIMENTAL

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

Interventions

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

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

Also known as: Codeine/ Acetaminophen (Co/Ac)
Co/ Ac
Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 daysDRUG

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

Also known as: Tramadol/ Acetaminophen (Tr/Ac)
Tr/ Ac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periapical AbscessAgnosia

Interventions

acetaminophen, codeine drug combinationUltracet

Condition Hierarchy (Ancestors)

AbscessSuppurationInfectionsPeriapical PeriodontitisPeriapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 25, 2016

Study Start

April 1, 2013

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

April 25, 2016

Record last verified: 2016-04