Pain ManagementPhase 4SAILS-SteroidNCT06074263
Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid
A Phase 4 study testing Dexamethasone 8mg in people with Pain Management, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
To provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics and use of corticosteroid for acute post-surgical pain management; a pilot double blind randomized clinical trial will be conducted to test the hypothesis that use of… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Dexamethasone 8mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 31 Dec 2024
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to understand the informed consent.
- Provide signed and dated informed consent form
- Be able to understand all directions for data gathering instruments in English
- Be willing and able to comply with all study procedures, including having a smart phone, and be available for the duration of the study
- Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars
- Be 18 years or older
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- Be in good general health as evidenced by medical history
- Women must agree to use one of the following methods of contraception while participating in this study:
- contraceptive pill
- intra-uterine device
- condoms
- abstinence
Who cannot join
- • History of gastrointestinal bleeding, diverticulitis and/or ulcerative disease
- History of renal disease (excluding kidney stones)
- History of hepatic disease
- History of cardiovascular disease (MI or stroke with the past 6 months)
- History of bleeding disorder
- History of Sickle Cell disease
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- Active or untreated asthma
- History of known allergic reaction to ibuprofen, acetaminophen, or dexamethasone
- History of myasthenia gravis
- Currently immunocompromised
- Currently have a fungal infection
- Currently taking steroids
- Currently pregnant or lactating
- Currently taking CYP3A4 inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
About this study
To provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics and use of corticosteroid for acute post-surgical pain management; a pilot double blind randomized clinical trial will be conducted to test the hypothesis that use of preemptive dose of corticosteroid will reduce the need for opioid rescue. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results, as well as the fact that dentists write about one third of opioid prescriptions for adolescents.
Read the detailed description
The primary objective of this pilot study is to determine whether a STEROID (1 dose of 8 mg dexamethasone) is superior to CONTROL in pain management and patient satisfaction observed for seven days following 3rd molar extraction, for the relief of acute post-surgical pain.
A double blind, prospective, randomized quasi-pragmatic clinical trial comparing a preemptive dose of 8mg dexamethasone to control will be conducted. Both STEROID and CONTROL will be provided 400 mg ibuprofen and 500 mg acetaminophen as analgesics.
The Research Coordinator will obtain consent with the potential participant followed by a detailed review of inclusion and exclusion criteria. The 3rd molar surgery appointment will occur within 3 months (93) days after obtaining consent, and randomization will occur prior to the 3rd molar extraction procedure. Randomization will be performed within each site, stratified by gender to ensure that randomization procedures will apply equally to men and women. Subgroup analyses will be performed.
The steroid intervention will be administered just prior to surgery, and participants will be followed for 9 (-/+5) days post-surgery during which subjects will take the non-opioid combination analgesics as needed for pain. This represents the time between surgery and the post-operative visit, covering the entire acute pain phase which is normally 7-10 days long. At Visit 1 (Surgery Visit), a pre-surgical saliva sample will be obtained, participants will complete a Pre-Operative Subject Questionnaire addressing pain intensity, pain interference, sleep, and overall satisfaction and a post-surgical saliva sample obtained. During the post-operative period, participants will be asked to complete a diary with morning and evening entries. They will also be asked to collect 8 additional saliva samples: for the first three days just prior to going to sleep and for three day just after getting up in the morning, as well, the night before their post-operative exam and the morning of their post-operative exam. When the participant returns for his/her post-operative visit, generally 7 to 10 days after surgery, he/she will return the pill bottles or blister pack with unused medication and a survey will be administered.
- Conditions
- Pain Management
- Being tested
- Dexamethasone 8mg, Placebo
- Keywords
- Pain, Analgesic, Steroid
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 8mgDrug
Dexamethasone 8mg will be taken orally just prior to surgery.
PlaceboOther
Placebo capsule which looks identical to dexamethasone capsule
| Study group | Role | What they receive |
|---|---|---|
| Steroid | Experimental | Dexamethasone 8mg Receives: Drug: Dexamethasone 8mg |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Experience
The arithmetic mean of ratings to four questions -- What is the worst pain, What is the least pain,W is the average pain and How much pain do you feel now on a a numeric rating scale from 0 to 10 where 0 =no pain ) to 10 (the worst pain you can imagine) over the last 12 hours. (Higher number is greater pain)
Measured: 24, 48 and 72 hours
Satisfaction With Medication
13 question surveys asking about the participants satisfaction with pain management medication.. Questions ask about pain management, pain interference, and adverse events. Using Likert scales participants are asked how satisfied they are with the (1) ability of the study medication to control their pain, (2) time it took for pain medication to work, (3) amount of pain relief provided by their pain medication, (4) duration of the pain relief provided by their medication, (5) extent side effects interfered with their ability to carry out daily functions, extent side effects affected their cognitive function and (6) extent did side effects affected their mental state. Participants are also asked (1) did their level of pain relief meet their expectations and (2) overall, taking everything into account, how satisfied were they with their study pain medication. The sum of the Likert scale results will be calculated. A higher score indicates greater satisfaction.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start27 Nov 2023
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Why it stopped: Terminated after 8 participants as prospect for funded is no longer viable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Impacted Mandibular 3rd Molar Extraction Model
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey
- Investigators
- Cecile Feldman, DMD, BMA, Principal investigator, Rutgers University, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074263
- Sponsor's protocol ID
- Pro2023001077
- Acronym
- SAILS-Steroid
- Status last verified
- May 2025
- First submitted
- 27 Sep 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot study, there is no plan to share data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid
- ClinicalTrials.gov ID
- NCT06074263
- Acronym / sponsor ID
- SAILS-Steroid / Pro2023001077
- Conditions
- Pain Management
- Keywords
- Pain, Analgesic, Steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated after 8 participants as prospect for funded is no longer viable
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Oct 2023 (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.
To provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics and use of corticosteroid for acute post-surgical pain management; a pilot double blind randomized clinical trial will be conducted to test the hypothesis that use of preemptive dose of corticosteroid will reduce the need for opioid rescue. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results, as well as the fact that dentists write about one third of opioid prescriptions for adolescents.
Detailed description
The primary objective of this pilot study is to determine whether a STEROID (1 dose of 8 mg dexamethasone) is superior to CONTROL in pain management and patient satisfaction observed for seven days following 3rd molar extraction, for the relief of acute post-surgical pain.
A double blind, prospective, randomized quasi-pragmatic clinical trial comparing a preemptive dose of 8mg dexamethasone to control will be conducted. Both STEROID and CONTROL will be provided 400 mg ibuprofen and 500 mg acetaminophen as analgesics.
The Research Coordinator will obtain consent with the potential participant followed by a detailed review of inclusion and exclusion criteria. The 3rd molar surgery appointment will occur within 3 months (93) days after obtaining consent, and randomization will occur prior to the 3rd molar extraction procedure. Randomization will be performed within each site, stratified by gender to ensure that randomization procedures will apply equally to men and women. Subgroup analyses will be performed.
The steroid intervention will be administered just prior to surgery, and participants will be followed for 9 (-/+5) days post-surgery during which subjects will take the non-opioid combination analgesics as needed for pain. This represents the time between surgery and the post-operative visit, covering the entire acute pain phase which is normally 7-10 days long. At Visit 1 (Surgery Visit), a pre-surgical saliva sample will be obtained, participants will complete a Pre-Operative Subject Questionnaire addressing pain intensity, pain interference, sleep, and overall satisfaction and a post-surgical saliva sample obtained. During the post-operative period, participants will be asked to complete a diary with morning and evening entries. They will also be asked to collect 8 additional saliva samples: for the first three days just prior to going to sleep and for three day just after getting up in the morning, as well, the night before their post-operative exam and the morning of their post-operative exam. When the participant returns for his/her post-operative visit, generally 7 to 10 days after surgery, he/she will return the pill bottles or blister pack with unused medication and a survey will be administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Impacted Mandibular 3rd Molar Extraction Model
| Arm | Type | Receives |
|---|---|---|
| Steroid | Experimental | Drug: Dexamethasone 8mgDexamethasone 8mg |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be able to understand the informed consent.
Key exclusion criteria (14 listed)
- • History of gastrointestinal bleeding, diverticulitis and/or ulcerative disease
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 |
|---|---|---|
| Dexamethasone 8mgDexamethasone 8mg will be taken orally just prior to surgery. | Drug | Steroid |
| PlaceboPlacebo capsule which looks identical to dexamethasone capsule | Other | Placebo |
Primary outcome
Pain Experience
Time frame: 24, 48 and 72 hours
The arithmetic mean of ratings to four questions -- What is the worst pain, What is the least pain,W is the average pain and How much pain do you feel now on a a numeric rating scale from 0 to 10 where 0 =no pain ) to 10 (the worst pain you can imagine) over the last 12 hours. (Higher number is greater pain)
Satisfaction With Medication
Time frame: 72 hours
13 question surveys asking about the participants satisfaction with pain management medication.. Questions ask about pain management, pain interference, and adverse events. Using Likert scales participants are asked how satisfied they are with the (1) ability of the study medication to control their pain, (2) time it took for pain medication to work, (3) amount of pain relief provided by their pain medication, (4) duration of the pain relief provided by their medication, (5) extent side effects interfered with their ability to carry out daily functions, extent side effects affected their cognitive function and (6) extent did side effects affected their mental state. Participants are also asked (1) did their level of pain relief meet their expectations and (2) overall, taking everything into account, how satisfied were they with their study pain medication. The sum of the Likert scale results will be calculated. A higher score indicates greater satisfaction.
Results and safety
The study was stopped early (reason given: Terminated after 8 participants as prospect for funded is no longer viable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No. As this is a pilot study, there is no plan to share data with other researchers.
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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.
Cecile Feldman, DMD, BMA principal investigator
Rutgers University, 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 Dexamethasone 8mg in people with Pain Management, run by Rutgers, The State University of New Jersey 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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 4 Jun 2025. 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. 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.
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 stopped early (reason given: Terminated after 8 participants as prospect for funded is no longer viable). Results are not available in the source record.
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 Experience (time frame: 24, 48 and 72 hours). The study lists 2 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 4 Jun 2025.