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

NCT06074263 | Terminated Phase 4

• 1 other identifier: Pro2023001077
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain Management

Keywords

Pain; Analgesic; Steroid

Outcome Measures

Primary Outcomes (2)

• Pain Experience

  The arithmetic mean of ratings to four questions -- What is the worst pain, What is the least pain,W is the average pain and How much pain do you feel now on a a numeric rating scale from 0 to 10 where 0 =no pain ) to 10 (the worst pain you can imagine) over the last 12 hours. (Higher number is greater pain)

  24, 48 and 72 hours

• Satisfaction With Medication

  13 question surveys asking about the participants satisfaction with pain management medication.. Questions ask about pain management, pain interference, and adverse events. Using Likert scales participants are asked how satisfied they are with the (1) ability of the study medication to control their pain, (2) time it took for pain medication to work, (3) amount of pain relief provided by their pain medication, (4) duration of the pain relief provided by their medication, (5) extent side effects interfered with their ability to carry out daily functions, extent side effects affected their cognitive function and (6) extent did side effects affected their mental state. Participants are also asked (1) did their level of pain relief meet their expectations and (2) overall, taking everything into account, how satisfied were they with their study pain medication. The sum of the Likert scale results will be calculated. A higher score indicates greater satisfaction.

  72 hours

Study Arms (2)

Steroid

EXPERIMENTAL

Dexamethasone 8mg

Drug: Dexamethasone 8mg

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Dexamethasone 8mg DRUG

Dexamethasone 8mg will be taken orally just prior to surgery.

Steroid

Placebo OTHER

Placebo capsule which looks identical to dexamethasone capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Cecile Feldman, DMD, BMA

  Rutgers University, School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Dexamethasone 8mg is being provided in a capsule. The placebo is also being provided in the same capsule.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean & Distinguished Professor

Model Details: Impacted Mandibular 3rd Molar Extraction Model

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: November 27, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)