Status:
TERMINATED
Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Pain Management
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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 p...
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 fo...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06074263
Start Date
November 27 2023
End Date
December 31 2024
Last Update
June 4 2025
Active Locations (1)
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1
Rutgers School of Dental Medicine
Newark, New Jersey, United States, 07103