Periapical AbscessNCT02750696
Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess
A study testing Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days and Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days in people with Periapical Abscess, run by Federal University of Rio Grande do Sul.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Abscess
- What is being tested?
- Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days and Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
About this study
Official title: Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial
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.
- Conditions
- Periapical Abscess
- Being tested
- Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days, Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days
- Keywords
- Acetaminophen, Analgesia, Codeine, Drug Combinations, Endodontics, Periapical abscess, Randomized Controlled Trial, Tramadol, Visual analog scale
- Medical subject headings
- Periapical Abscess, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 daysDrug
Also called Codeine/ Acetaminophen (Co/Ac)
Patients in this group received opioid/ non-opioid analgesic combination.
Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 daysDrug
Also called Tramadol/ Acetaminophen (Tr/Ac)
Patients in this group received opioid/ non-opioid analgesic combination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain scores over time.
Pain scores were obtained using VAS before and after the first appointment.
Measured: 0, 6, 12, 24, 48 and 72 h after first dose administration
Secondary outcomes (2)
Frequency of additional medication
Registered in the pain diary by the patient.
Measured: Up to 72 hours
Adverse reactions reported by patients
Registered in the pain diary by the patient.
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Manuela Favarin Santin, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750696
- Sponsor's protocol ID
- 12671913.1.0000.5347
- Status last verified
- Apr 2016
- First submitted
- 15 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02750696
- Acronym / sponsor ID
- 12671913.1.0000.5347
- Conditions
- Periapical Abscess
- Keywords
- Acetaminophen, Analgesia, Codeine, Drug Combinations, Endodontics, Periapical abscess, Randomized Controlled Trial, Tramadol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co/ Ac | Active comparator | Drug: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 daysCodeine/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. |
| Tr/ Ac | Experimental | Drug: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 daysTramadol/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 daysAlso: Codeine/ Acetaminophen (Co/Ac)Patients in this group received opioid/ non-opioid analgesic combination. | Drug | Co/ Ac |
| Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 daysAlso: Tramadol/ Acetaminophen (Tr/Ac)Patients in this group received opioid/ non-opioid analgesic combination. | Drug | Tr/ Ac |
Primary outcome
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.
2 secondary outcomes
Frequency of additional medication
Time frame: Up to 72 hours
Adverse reactions reported by patients
Time frame: Up to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
Related trials for Periapical Abscess
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Recruiting
Antibacterial Effects of Intracanal Medicaments in Acute Apical Abscesses
Acute Apical Abscess
RecruitingPhase 1
Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases
Intervention Studies, ASA Physical Status I
Not yet recruitingEarly Phase 1
Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial
Pulp Disease, Dental, Pulp Necrosis
Not yet recruiting
Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
Chronic Apical Periodontitis, Necrosis of Pulp
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days and Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days in people with Periapical Abscess, run by Federal University of Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pain scores over time. (time frame: 0, 6, 12, 24, 48 and 72 h after first dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.