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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Dexamethasone

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