Clinical trial NCT06074263: Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid
Official title: Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain Management
Keywords: Pain
Analgesic
Steroid
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Impacted Mandibular 3rd Molar Extraction Model
Primary purpose: SUPPORTIVE_CARE

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.

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 following 3rd molar extraction, for the relief of acute post-surgical pain.

A double blind, prospective, randomized quasi-pragmatic clinical trial comparing a preemptive dose of 8mg dexamethasone to control will be conducted. Both STEROID and CONTROL will be provided 400 mg ibuprofen and 500 mg acetaminophen as analgesics.

The Research Coordinator will obtain consent with the potential participant followed by a detailed review of inclusion and exclusion criteria. The 3rd molar surgery appointment will occur within 3 months (93) days after obtaining consent, and randomization will occur prior to the 3rd molar extraction procedure. Randomization will be performed within each site, stratified by gender to ensure that randomization procedures will apply equally to men and women. Subgroup analyses will be performed.

The steroid intervention will be administered just prior to surgery, and participants will be followed for 9 (-/+5) days post-surgery during which subjects will take the non-opioid combination analgesics as needed for pain. This represents the time between surgery and the post-operative visit, covering the entire acute pain phase which is normally 7-10 days long. At Visit 1 (Surgery Visit), a pre-surgical saliva sample will be obtained, participants will complete a Pre-Operative Subject Questionnaire addressing pain intensity, pain interference, sleep, and overall satisfaction and a post-surgical saliva sample obtained. During the post-operative period, participants will be asked to complete a diary with morning and evening entries. They will also be asked to collect 8 additional saliva samples: for the first three days just prior to going to sleep and for three day just after getting up in the morning, as well, the night before their post-operative exam and the morning of their post-operative exam. When the participant returns for his/her post-operative visit, generally 7 to 10 days after surgery, he/she will return the pill bottles or blister pack with unused medication and a survey will be administered.

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

Primary outcomes:
measure: Pain Experience
timeFrame: 24, 48 and 72 hours
measure: Satisfaction With Medication
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
Study officials:
affiliation: Rutgers University, School of Dental Medicine
name: Cecile Feldman, DMD, BMA
role: PRINCIPAL_INVESTIGATOR
References: