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

Pain Management Clinical Trial

— SAILS-Steroid  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074263
• Other study ID #: Pro2023001077
• Status: Recruiting
• Phase: Phase 4
• Start date: November 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Cecile A Feldman, DMD, MBA
• Phone: 973-972-4634
• Email: feldman[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Management

Intervention

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

Other:
• Placebo
Placebo capsule which looks identical to dexamethasone capsule

Locations

Country	Name	City	State
United States	Rutgers School of Dental Medicine	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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