Opioid Management for Broken Bones

Overseen By Geoffrey Capraro, MD, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Addinex Technologies, Inc.

Must not be taking: Opioids

Disqualifiers: Impaired decisional capacity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called Addinex to manage pain with fewer opioids after a broken bone. The study aims to determine if Addinex can reduce pill consumption, assist in disposing of extra pills, and identify patterns in opioid use. Participants will either use the Addinex system or follow standard pain management practices. Suitable candidates have a bone fracture, will take opioids for pain, and are comfortable using smartphone apps. As an unphased trial, this study allows participants to contribute to innovative pain management solutions that could benefit future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not be taking opioids daily before the procedure.

What prior data suggests that the Addinex system is safe for opioid dispensing?

Research has shown that the Addinex system, which helps manage opioid use after bone fractures, is generally safe when side effects are anticipated and managed. Opioids can cause issues like breathing difficulties, but proper care can address these. Specific safety data on Addinex itself is not yet available, as the trial is in an early stage called "Not Applicable," meaning safety information is limited. Prospective participants should note that the trial aims to determine if Addinex can reduce opioid use and enhance safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Addinex because it offers a novel approach to managing pain from broken bones, aiming to reduce reliance on opioids. Unlike traditional methods that rely heavily on opioid medication, Addinex uses a system designed to optimize pain management and potentially minimize opioid use. This system could help prevent opioid addiction and side effects by providing a controlled, efficient way of administering pain relief. By bringing a fresh perspective to pain management, Addinex has the potential to enhance recovery experiences for both adults and children suffering from bone fractures.

What evidence suggests that the Addinex system is effective for opioid management after broken bones?

Research has shown that opioids effectively manage pain after surgeries, such as when treating a broken bone. However, they can cause side effects like nausea and carry a risk of addiction. In this trial, some participants will use the Addinex system, designed to manage opioid use by controlling their dispensation. This system may reduce the amount taken and assist with safe disposal. Although specific data on Addinex's effectiveness is limited, the system aims to address issues related to opioid use and safety. This approach is expected to make opioid use safer and potentially lower associated risks. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have been treated in the emergency department for broken bones and are being discharged with a prescription for opioids. Specific eligibility criteria details are not provided.

Inclusion Criteria

Able to give informed consent or a parent that can give informed consent

I can swallow pills.

I am not using opioids every day before the procedure.

Exclusion Criteria

In police custody

Ward of the state

Recent opioid use (last 30 days or 2 or more prescriptions in the past 3 months)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive at-home acute pain management using either the Addinex system or standard opioid dispensing after treatment for isolated bone fracture

1 month

Same day treatment

Follow-up

Participants are monitored for opioid consumption, disposal rates, and pain levels

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Addinex

Trial Overview The study is testing the Addinex system, which dispenses opioids, against standard pill bottles to see if it reduces opioid use, improves disposal of unused pills, identifies predictors of opioid use, and assesses patient acceptance.

How Is the Trial Designed?

Group I: Device Child Experimental Treatment 1 Intervention

Patients in this arm will be children who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25)

Group II: Device Adult Experimental Treatment 1 Intervention

Patients in this arm will be adults who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25)

Group III: Control Adult Active Control 1 Intervention

Patients in this arm will be adults who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25)

Group IV: Control Child Active Control 1 Intervention

Patients in this arm will be children who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25)

Who Is Running the Clinical Trial?

Addinex Technologies, Inc.

Lead Sponsor

Trials

2

Recruited

110+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study of 13,389 opioid-free patients who underwent surgery, 9.1% experienced opioid-related adverse drug events (ORADEs) after receiving postoperative opioids, highlighting a significant risk in this population.

Patients with ORADEs faced severe consequences, including 32% higher hospitalization costs, 45% longer hospital stays, and 2.2 times the odds of mortality, emphasizing the need for careful management of opioid use post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. Urman, RD., Seger, DL., Fiskio, JM., et al.[2023]

Opioid-related adverse drug events (ADEs) significantly increase hospital costs by 7.4% and length of stay (LOS) by 10.3% in surgical patients, indicating a substantial financial impact on healthcare systems.

Patients receiving higher doses of opioids are at a greater risk of experiencing ADEs, suggesting that careful management of opioid dosages is crucial to minimize complications and associated costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Oderda, GM., Said, Q., Evans, RS., et al.[2022]

Opioids can be effective and relatively safe options for managing pain, but they are often avoided due to concerns about potential side effects and adverse events.

The side effects of opioids can affect multiple body systems, but with proper management and quick intervention, these effects can be addressed, allowing opioids to be used safely and effectively for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. Herndon, CM., Kalauokalani, DA., Cunningham, AJ., et al.[2019]

The implementation of an opioid-free multimodal pain regimen in 313 patients undergoing minimally invasive lobectomy resulted in significantly lower postoperative opioid use, with 56% of patients requiring no oral opioids and 91% not using a patient-controlled analgesia pump.

Patients on the opioid-free protocol experienced lower average pain scores and a dramatic increase in the percentage of patients discharged without an opioid prescription (62% compared to 7% previously), which may help reduce the risk of opioid addiction in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Pain Management Protocol to Decrease Opioid Use and to Improve Pain Control After Thoracic Surgery. Clark, IC., Allman, RD., Rogers, AL., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06592378?cond=%22Fractures,%20Bone%22&aggFilters=status:not%20rec&rank=5

Study Details | NCT06592378 | Opioid Management for ... Patients in this arm will be adults who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25).

2. withpower.com withpower.com/trial/opioid-management-for-broken-bones-873f0

Opioid Management for Broken Bones The research suggests that opioids are effective for managing pain after surgeries, including those for broken bones, but they can have side effects like nausea ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5726569/

Oxycodone Ingestion Patterns in Acute Fracture Pain with ... Participants ingested a median of 6 (3–9.5) oxycodone digital pills over the course of 7 days, with 82% of the oxycodone dose ingested in the first 3 days.

4. bmcemergmed.biomedcentral.com bmcemergmed.biomedcentral.com/articles/10.1186/s12873-024-00933-y

Comparing the efficacy of intravenous morphine versus ... The study findings suggest that ibuprofen and its combination with acetaminophen have similar or better analgesic effects compared to morphine in patients with ...

5. reporter.nih.gov reporter.nih.gov/project-details/9869756

Health Impacts of Prehospital Pain Management for Injured ... Approximately 10% of injured older adults receive opioid analgesia for pain management during the prehospital interval, or the time from the onset of injury ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29189367/

Oxycodone Ingestion Patterns in Acute Fracture Pain With ... Understanding patterns of actual opioid ingestion after acute painful conditions can help clinicians counsel patients on safe opioid use, and allow timely ...

7. jposna.org jposna.org/index.php/jposna/article/download/220/184

Pain Management in Acute Fracture Care - JPOSNA.org In the acute setting, bone pain will typically be “sharp” when it originates from the periosteum and dull when it originates from the medullary cavity/marrow.22 ...