Opioid Management for Broken Bones

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Addinex Technologies, Inc.

No Placebo Group

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.

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.

+7 more

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)

+1 more

Participant Groups

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.

4Treatment groups

Experimental Treatment

Active Control

Group I: Device ChildExperimental Treatment1 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 AdultExperimental Treatment1 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 AdultActive Control1 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 ChildActive Control1 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)