TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-27
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06074263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be able to understand the informed consent.
  2. * Provide signed and dated informed consent form
  3. * Be able to understand all directions for data gathering instruments in English
  4. * Be willing and able to comply with all study procedures, including having a smart phone, and be available for the duration of the study
  5. * Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars
  6. * Be 18 years or older
  7. * Be in good general health as evidenced by medical history
  8. * Women must agree to use one of the following methods of contraception while participating in this study:
  9. * contraceptive pill
  10. * intra-uterine device
  11. * condoms
  12. * abstinence
  1. * • History of gastrointestinal bleeding, diverticulitis and/or ulcerative disease
  2. * History of renal disease (excluding kidney stones)
  3. * History of hepatic disease
  4. * History of cardiovascular disease (MI or stroke with the past 6 months)
  5. * History of bleeding disorder
  6. * History of Sickle Cell disease
  7. * Active or untreated asthma
  8. * History of known allergic reaction to ibuprofen, acetaminophen, or dexamethasone
  9. * History of myasthenia gravis
  10. * Currently immunocompromised
  11. * Currently have a fungal infection
  12. * Currently taking steroids
  13. * Currently pregnant or lactating
  14. * Currently taking CYP3A4 inhibitors

Contacts and Locations

Principal Investigator

Cecile Feldman, DMD, BMA
PRINCIPAL_INVESTIGATOR
Rutgers University, School of Dental Medicine

Study Locations (Sites)

Rutgers School of Dental Medicine
Newark, New Jersey, 07103
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Cecile Feldman, DMD, BMA, PRINCIPAL_INVESTIGATOR, Rutgers University, School of Dental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Pain
  • Analgesic
  • Steroid

Additional Relevant MeSH Terms

  • Pain Management