PainNCT02865746
Betamethasone to Control Postoperative Pain in Emergency Endodontic Care
A study testing Bethametasone in people with Pain, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
The objective of this randomized double-blind study was to evaluate the effect of betamethasone in the control of postoperative pain in patients undergoing endodontic treatment. Read more about this study
- Who is it for?
- Ages 10 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Bethametasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2004to Dec 2005
- 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 10 to 72 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals had to have a tooth with pain of endodontic origin justifying emergency care;
- Individuals diagnosed with irreversible pulpitis or necrosis associated to pericementitis.
Who cannot join
- Individuals who presented:
- Pregnancy or lactation;
- Use of corticosteroids;
- History of hypersensitivity to the drugs used in this study;
- Pain associated with abscesses of endodontic origin;
- Individuals with tuberculosis;
Show all 11Show fewer
- Individuals with systemic fungal infections;
- Individuals with simple ocular herpes;
- Individuals with glaucoma;
- Individuals with acute psychosis.
- Individuals with psychotic tendencies.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, 39100000
About this study
Official title: Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial
The objective of this randomized double-blind study was to evaluate the effect of betamethasone in the control of postoperative pain in patients undergoing endodontic treatment.
Read the detailed description
To prevent post endodontic treatment pain, systemic administration of corticosteroids may have their effect maximized if the infiltration is performed in the oral mucosa, near the periapex of the tooth, which concentrates the inflammatory process. The administration of corticosteroids at this moment, taking advantage of the anesthetic effect still present, ensures continuous comfort during the postoperative period.
The objective of this randomized double-blind clinical trial was to evaluate the effect of the systemic administration of betamethasone - through infiltration in the oral mucosa - to control pain and edemas in patients undergoing emergency endodontic treatment.
- Conditions
- Pain
- Being tested
- Bethametasone, Placebo
- Keywords
- Steroids, Pain measurement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BethametasoneDrug
Also called Group 1
The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.
PlaceboDrug
Also called Group 2
The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.
| Study group | Role | What they receive |
|---|---|---|
| Group betamethasone | Active comparator | Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg Receives: Drug: Bethametasone |
| Group placebo | Placebo comparator | sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
During the post-surgical interval of 4 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Measured: 4 hours after treatment
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
During the post-surgical interval of 24 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Measured: 24 hours after treatment
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
During the post-surgical interval of 48 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Measured: 48 hours after treatment
Secondary outcomes (3)
Analgesic consumption
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Measured: 4 hours after treatment
Analgesic consumption
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Measured: 24 hours after treatment
Analgesic consumption
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Measured: 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJul 2004
- Primary completionMay 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Sponsor
- Investigators
- Marcos P. Pinheiro, PhD, Principal investigator, Federal University of Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865746
- Sponsor's protocol ID
- ufvjm
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02865746
- Acronym / sponsor ID
- ufvjm
- Conditions
- Pain
- Keywords
- Steroids, Pain measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- Jul 2004
- Primary completion
- May 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 12 Aug 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.
The objective of this randomized double-blind study was to evaluate the effect of betamethasone in the control of postoperative pain in patients undergoing endodontic treatment.
Detailed description
To prevent post endodontic treatment pain, systemic administration of corticosteroids may have their effect maximized if the infiltration is performed in the oral mucosa, near the periapex of the tooth, which concentrates the inflammatory process. The administration of corticosteroids at this moment, taking advantage of the anesthetic effect still present, ensures continuous comfort during the postoperative period.
The objective of this randomized double-blind clinical trial was to evaluate the effect of the systemic administration of betamethasone - through infiltration in the oral mucosa - to control pain and edemas in patients undergoing emergency endodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group betamethasone | Active comparator | Drug: BethametasoneActive Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg |
| Group placebo | Placebo comparator | Drug: Placebosterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg |
Who may qualify
- Ages
- 10 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals had to have a tooth with pain of endodontic origin justifying emergency care;
- Individuals diagnosed with irreversible pulpitis or necrosis associated to pericementitis.
Key exclusion criteria (11 listed)
- Pregnancy or lactation;
- Use of corticosteroids;
- History of hypersensitivity to the drugs used in this study;
- Pain associated with abscesses of endodontic origin;
- Individuals with tuberculosis;
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 |
|---|---|---|
| BethametasoneAlso: Group 1The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique. | Drug | Group betamethasone |
| PlaceboAlso: Group 2The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique. | Drug | Group placebo |
Primary outcome
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
Time frame: 4 hours after treatment
During the post-surgical interval of 4 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
Time frame: 24 hours after treatment
During the post-surgical interval of 24 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
Time frame: 48 hours after treatment
During the post-surgical interval of 48 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
3 secondary outcomes
Analgesic consumption
Time frame: 4 hours after treatment
Analgesic consumption
Time frame: 24 hours after treatment
Analgesic consumption
Time frame: 48 hours after treatment
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 12 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Marcos P. Pinheiro, PhD principal investigator
Federal University of Valleys of Jequitinhonha and Mucuri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bethametasone in people with Pain, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
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 2 inclusion and 11 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 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Pain determined using the "Point Verbal Rating Scale - Modified VRS4" (time frame: 4 hours after treatment). The study lists 3 primary outcomes in all. 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 12 Aug 2016.