Optimizing Non-Opioid Pain Management with a Steroid for Dental Surgery

Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid

This study is testing if a single dose of a steroid can help people manage pain better after having their wisdom teeth removed, compared to a placebo, while they take regular pain relievers.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Rutgers, The State University of New Jersey (Academic / other)
• Locations: 1 site (Newark, New Jersey)
• Trial ID: NCT06074263 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the effectiveness of a single preemptive dose of dexamethasone in managing acute post-surgical pain following the extraction of impacted third molars. Conducted as a double-blind, randomized clinical trial, participants will receive either the steroid or a placebo alongside standard non-opioid analgesics (ibuprofen and acetaminophen). The study will assess pain relief and patient satisfaction over a seven-day period post-surgery, with randomization stratified by gender to ensure balanced representation. The findings will provide valuable insights for healthcare professionals in optimizing pain management strategies and reducing opioid prescriptions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for the extraction of one or more impacted mandibular third molars and are in good general health.

Not a fit: Patients with a history of gastrointestinal, renal, hepatic, or cardiovascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the need for opioid pain relief in post-surgical patients, thereby minimizing the risk of opioid dependence.

How similar studies have performed: Other studies have shown promising results with non-opioid analgesics and corticosteroids in pain management, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* 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
  * 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

Exclusion Criteria:

* • 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
  * 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

Where this trial is running

Newark, New Jersey

• Rutgers School of Dental Medicine — Newark, New Jersey, United States (Recruiting)

Study contacts

• Principal investigator: Cecile Feldman, DMD, BMA — Rutgers University, School of Dental Medicine
• Study coordinator: Cecile A Feldman, DMD, MBA

Conditions Pain Management; Pain; Analgesic; Steroid