Oral SurgeryPhase 4NCT04008043
Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain
A Phase 4 study testing Vicodin and Dexamethasone in people with Oral Surgery, run by Boston University at 1 site in United States.
Trial summary
The main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Oral Surgery
- What is being tested?
- Vicodin and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2020to May 2021
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be scheduled for periodontal surgery
- Subjects must be aged 21 years old and above
- Able and willing to provide informed consent
- 20 non-obese patients with BMI less than 30kg/m2
- 20 obese patients with BMI greater than or equal to 30kg/m2
- Diabetic and hypertensive patients included
Who cannot join
- Patients allergic to any formulations used in the study
- Patients with chronic use of nonsteroidal anti-inflammatory drugs or chronic use of narcotics; chronic defined as frequent use or misuse/ abuse so much as once a month
- Pregnant or lactating female patients; pregnancy test will be performed alongside the medical history
- Patients with kidney dysfunction
- Patients at risk for infective endocarditis determined by the medical history or past medical records
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry M. Goldman School of Dental Medicine
Boston, Massachusetts, 02118
About this study
Official title: The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study
The main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. To provide a sample estimate of the population parameter which is the true value in the target population to be used in the planning of a larger confirmatory study.
Secondary objectives include:
Read more
To examine the efficacy of pre/post-operational administration of dexamethasone vs Vicodin (acetaminophen and hydrocodone) for post-operative pain control following periodontal surgery at the Henry M. Goldman School of Dental Medicine.
To examine how BMI alters the response to dexamethasone and hydrocodone following periodontal surgery since obese patients have shown higher pain scores and increased pain sensitivity in previous experimental models of pain.
- Conditions
- Oral Surgery
- Being tested
- Vicodin, Dexamethasone
- Keywords
- Dexamethasone, Vicodin, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VicodinDrug
Also called acetaminophen and hydrocodone
In addition to taking one tablet of vicodin for pain every 4-6 hours up to 8 tablets, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
DexamethasoneDrug
Also called corticosteroid
In addition to taking one tablet of dexamethasone for pain beginning the day before surgery and on the day of surgery, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Participants in this arm will take a 6mg dexamethasone tablet the day before surgery, a 6 mg tablet the day of surgery, a 4mg tablet the day after surgery and a 2mg tablet the second day after surgery. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery. Receives: Drug: Dexamethasone |
| Vicodin | Active comparator | Participants in this arm will take a vicodin tablet every 4-6 hrs as needed to a maximum of 8 tablets after surgery. Each tablet has 300 mg acetaminophen and 5 mg hydrocodone. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery. Receives: Drug: Vicodin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study enrollment rate of eligible participants
The proportion of patients that provide consent for the study
Measured: 12 months
Secondary outcomes (3)
Number of participants with breakthrough pain
Measured: evening of the surgery, the day after the surgery and one week after the surgery
Number medications taken for breakthrough pain
Measured: evening of the surgery, the day after the surgery and one week after the surgery
Medications taken for breakthrough pain
Measured: evening of the surgery, the day after the surgery and one week after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startFeb 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Inadequate resources to start the study at this site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral SurgeryStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif Said, BDS, Principal investigator, BU Goldman School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008043
- Sponsor's protocol ID
- H-38061
- Status last verified
- Nov 2019
- First submitted
- 2 Jul 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study
- ClinicalTrials.gov ID
- NCT04008043
- Acronym / sponsor ID
- H-38061
- Conditions
- Oral Surgery
- Keywords
- Dexamethasone, Vicodin, Pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate resources to start the study at this site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 5 Jul 2019 (actual)
- 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 main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. To provide a sample estimate of the population parameter which is the true value in the target population to be used in the planning of a larger confirmatory study.
Secondary objectives include:
To examine the efficacy of pre/post-operational administration of dexamethasone vs Vicodin (acetaminophen and hydrocodone) for post-operative pain control following periodontal surgery at the Henry M. Goldman School of Dental Medicine.
To examine how BMI alters the response to dexamethasone and hydrocodone following periodontal surgery since obese patients have shown higher pain scores and increased pain sensitivity in previous experimental models of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneParticipants in this arm will take a 6mg dexamethasone tablet the day before surgery, a 6 mg tablet the day of surgery, a 4mg tablet the day after surgery and a 2mg tablet the second day after surgery. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery. |
| Vicodin | Active comparator | Drug: VicodinParticipants in this arm will take a vicodin tablet every 4-6 hrs as needed to a maximum of 8 tablets after surgery. Each tablet has 300 mg acetaminophen and 5 mg hydrocodone. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be scheduled for periodontal surgery
- Subjects must be aged 21 years old and above
- Able and willing to provide informed consent
- 20 non-obese patients with BMI less than 30kg/m2
- 20 obese patients with BMI greater than or equal to 30kg/m2
Key exclusion criteria (5 listed)
- Patients allergic to any formulations used in the study
- Patients with chronic use of nonsteroidal anti-inflammatory drugs or chronic use of narcotics; chronic defined as frequent use or misuse/ abuse so much as once a month
- Pregnant or lactating female patients; pregnancy test will be performed alongside the medical history
- Patients with kidney dysfunction
- Patients at risk for infective endocarditis determined by the medical history or past medical records
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 |
|---|---|---|
| VicodinAlso: acetaminophen and hydrocodoneIn addition to taking one tablet of vicodin for pain every 4-6 hours up to 8 tablets, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery. | Drug | Vicodin |
| DexamethasoneAlso: corticosteroidIn addition to taking one tablet of dexamethasone for pain beginning the day before surgery and on the day of surgery, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery. | Drug | Dexamethasone |
Primary outcome
Study enrollment rate of eligible participants
Time frame: 12 months
The proportion of patients that provide consent for the study
3 secondary outcomes
Number of participants with breakthrough pain
Time frame: evening of the surgery, the day after the surgery and one week after the surgery
Number medications taken for breakthrough pain
Time frame: evening of the surgery, the day after the surgery and one week after the surgery
Medications taken for breakthrough pain
Time frame: evening of the surgery, the day after the surgery and one week after the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Sherif Said, BDS principal investigator
BU Goldman School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vicodin and Dexamethasone in people with Oral Surgery, run by Boston University at 1 site in United States.
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 6 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: withdrawn, as of the sponsor's last update on 13 Nov 2019. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Study enrollment rate of eligible participants (time frame: 12 months). 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 13 Nov 2019; AzTrials last refreshed its copy on 3 Nov 2026.