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

8 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cecile Feldman, DMD, BMA

Principal Investigator

Rutgers University, School of Dental Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+