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Opioid Management for Broken Bones

N/A

Waitlist Available

Research Sponsored by Addinex Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not taking opioids daily prior to the procedure

Isolated bone fracture

Must not have

Impaired decisional capacity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post treatment

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the Addinex system for dispensing opioids after outpatient care. The researchers want to see if using this system can help lower opioid use, increase proper disposal of pills, identify

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on dispensing methods rather than medication itself, side effects would be related to the opioids prescribed. These can include nausea, drowsiness, constipation, addiction risk and others depending on the specific opioid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not using opioids every day before the procedure.

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I have a broken bone that is not related to any other injury.

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I am scheduled to receive pain medication after my treatment.

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I am not currently in the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty making decisions due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median pill consumption

Secondary study objectives

Median disposal of opioids

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

0 / 5Eligibility criteria met