Opioid Management for Discharged Emergency Department Patients

Conditions

• Bone Fractures

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Addinex — DEVICE
  Medication dispensing system to control and monitor opioid use
• Standard Pill Bottle — DEVICE
  Access and use of opioids in a standard pill bottle.

Study Details

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.

Key Dates

Start date

Jun 27, 2025

Status verified

Dec 2025

Primary completion

May 31, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Control Adult
  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)
• Active Comparator: Control Child
  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)
• Experimental: Device Adult
  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)
• Experimental: Device Child
  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)

Primary Outcome Measure

Median pill consumption [ Time Frame: One month post treatment ]

Central Contacts

• Geoffrey Capraro, MD, MPH
  508-410-2215
  [email protected]

Locations (1)

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