Dexamethasone for Pain Management

(SAILS-Steroid Trial)

Overseen By Cecile A Feldman, DMD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Steroids, CYP3A4 inhibitors

Disqualifiers: Renal, Hepatic, Cardiovascular, Asthma, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the steroid dexamethasone can manage pain after wisdom tooth surgery, potentially reducing opioid use. Researchers aim to determine if taking this medication before surgery can lessen postoperative pain. Participants will receive either dexamethasone or a placebo (a pill with no active ingredients) to compare results. Individuals planning to have their lower wisdom teeth removed, who are generally healthy, and have no history of certain health issues, such as gastrointestinal bleeding or kidney disease, may be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking steroids or CYP3A4 inhibitors (a type of medication that affects how drugs are processed in the body).

What is the safety track record for this treatment?

Research has shown that dexamethasone effectively and safely reduces pain after surgery. In several studies, patients who took dexamethasone experienced less pain and required fewer strong painkillers, like opioids, in the first 48 hours post-surgery. For instance, one study found that people using dexamethasone reported significantly lower pain levels up to 60 hours after surgery. Another study demonstrated that a second dose of dexamethasone further decreased the need for opioids immediately after surgery.

Overall, dexamethasone has been well-tolerated in these situations. It has been successfully used for pain control in surgeries such as joint replacements. Based on previous research, dexamethasone appears safe and effective for managing post-surgical pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dexamethasone is unique because it leverages its potent anti-inflammatory properties to address pain management differently from typical analgesics or opioids. Unlike standard pain relief options like NSAIDs or opioids, which often have significant side effects or dependency risks, dexamethasone is a corticosteroid that targets inflammation at the source. Researchers are particularly excited about its potential to provide effective pain relief with possibly fewer side effects and reduce the reliance on opioids, which are commonly used but carry high addiction risk.

What is the effectiveness track record for Dexamethasone in managing acute post-surgical pain?

Research has shown that dexamethasone reduces pain after surgery. In this trial, some participants will receive dexamethasone, while others will receive a placebo. Studies have found that patients receiving dexamethasone report less pain and require fewer strong painkillers, like opioids, in the first 48 hours post-surgery. This effect is particularly notable in joint surgeries. Dexamethasone can significantly reduce the need for opioids, which, while effective, can be addictive. This makes dexamethasone a promising option for managing pain after dental procedures, such as wisdom tooth extractions. Overall, dexamethasone has proven effective for pain relief in various surgeries. ^{1 2 4 6 7}

Who Is on the Research Team?

Cecile Feldman, DMD, BMA

Principal Investigator

Rutgers University, School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 in good health who are planning to have their wisdom teeth removed. Participants must understand and sign a consent form, follow study procedures, have a smartphone, and be available for the whole study. They should agree to use contraception like condoms or pills.

Inclusion Criteria

Be able to understand the informed consent

Be able to understand all directions for data gathering instruments in English

Be in good general health as evidenced by medical history

Exclusion Criteria

I currently have a fungal infection.

Currently pregnant or lactating

History of known allergic reaction to ibuprofen, acetaminophen, or dexamethasone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 3 months

1 visit (in-person)

Treatment

Participants receive a preemptive dose of 8mg dexamethasone or placebo prior to 3rd molar extraction, followed by non-opioid analgesics as needed

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for pain management and satisfaction, complete diaries, and provide saliva samples

9 days

1 visit (in-person)

Follow-up

Participants return for a post-operative visit to assess pain management and return unused medication

7-10 days after surgery

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The trial is testing if a steroid called Dexamethasone can reduce the need for opioid painkillers after wisdom tooth surgery. It's a pilot study where patients are randomly given either Dexamethasone or a placebo without knowing which one they receive.

How Is the Trial Designed?

Group I: Steroid Experimental Treatment 1 Intervention

Dexamethasone 8mg

Group II: Placebo Placebo Group 1 Intervention

Placebo

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5478317/

The efficiency and safety of dexamethasone for pain ... Dexamethasone could significantly reduce postoperative pain scores and opioid consumption within the 1st 48 hours following total joint arthroplasty (TJA).

2. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/143092-efficacy-of-weight-based-low-dose-intravenous-dexamethasone-for-pain-management-following-total-knee-arthroplasty-a-retrospective-case-matched-study

Efficacy of Weight-Based Low-Dose Intravenous ... The dexamethasone group demonstrated significantly lower pain scores at all measured intervals up to 60 hours postoperatively (p < 0.05) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21799397/

Perioperative single dose systemic dexamethasone for ... Dexamethasone at doses more than 0.1 mg/kg is an effective adjunct in multimodal strategies to reduce postoperative pain and opioid consumption after surgery.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2018/08310/a_meta_analysis_of_dexamethasone_for_pain.3.aspx

A meta-analysis of dexamethasone for pain management in... Use of dexamethasone could result in a significant reduction in postoperative pain while minimizing adverse effects after TKA.

5. epain.org epain.org/journal/view.html?doi=10.3344/kjp.2020.33.2.192

Comparing pain relief and functional improvement ... The percentage of subjects who reported improved function at 2, 3, and 6 months was 65%, 51%, and 41%, respectively, for the methylprednisolone ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118306277

Review The efficacy and safety of dexamethasone for pain ... Dexamethasone decreases pain scores within 48 h postoperatively and is associated with significantly reduced narcotic consumption.

7. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(23)00098-0/fulltext

A Second Dose of Dexamethasone Reduces Postoperative ... The administration of a second perioperative dexamethasone dose significantly decreased opioid consumption in the immediate postoperative period.