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

Trial Summary

What is the purpose of this trial?

The goal of this study is to analyze the use of the Addinex system for opioid dispensing after ambulatory care to determine whether it will reduce opioid consumption, increase pill disposal, show variables that may predict opioid consumption, and determine whether this intervention is acceptable to 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 data supports the effectiveness of the drug Addinex for managing pain from 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 and increased hospital costs. While the studies don't mention Addinex specifically, they highlight the importance of careful opioid management to control pain effectively. ^{1 2 3 4 5}

Is the opioid treatment for broken bones generally safe for humans?

Opioids are generally safe for pain management when side effects are anticipated and managed, but they can cause various adverse effects like respiratory issues and longer hospital stays if not properly monitored. ^{6 7 8 9 10}

How does this drug differ from other treatments for broken bones?

This treatment may involve the use of co-analgesics like dexamethasone to reduce the dosage and side effects of opioids, making it potentially safer and more effective than using opioids alone for managing pain from broken bones. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Review of Inpatient Opioid Consumption and Discharge Prescription Patterns After Orthopaedic Procedures. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Analgesics Administered for Pain During Hospitalization Following Lower Extremity Fracture: A Review of the Literature. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Household Income and Parental Educational Level Affect Post-Operative Opioid Usage in Pediatric Orthopaedic Patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cost of opioid-related adverse drug events in surgical patients. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Multimodal Pain Management Protocol to Decrease Opioid Use and to Improve Pain Control After Thoracic Surgery. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events and cost components related to the use of opioids in post-operative pain: a scoping review protocol. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Impact of Adoption of Smart Pump System With Continuous Capnography Monitoring on Opioid-Related Adverse Event Rates: Experience From a Tertiary Care Hospital. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Effect of a single bolus of dexamethasone on intraoperative and postoperative pain in unilateral inguinal hernia surgery. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Analgesics for orthopedic postoperative pain. [2010]

13. United States pubmed.ncbi.nlm.nih.gov

Opioid poorly-responsive cancer pain. Part 3. Clinical strategies to improve opioid responsiveness. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Evaluating the affect and reversibility of opioid-induced androgen deficiency in an orthopaedic animal fracture model. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Opioid Prescription and Usage in Adolescents Undergoing Orthopaedic Surgery in the United States: A Systematic Review. [2022]