CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 712 enrolled
Drug / intervention
Educational Intervention +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 3
  • Parent ≥21 years and child aged 5-17 living together in the home
  • Child prescribed an opioid for postoperative pain management
  • English speaking
Key exclusion· 5
  • Child undergoing a non-elective procedure
  • Child cannot self-report pain levels due to cognitive impairment
  • Child has hematologic or oncologic condition
  • Child has kidney or liver disease precluding standard opioid plus non-opioid analgesic regimen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03287622
NCT03287622N/ACompleted

Scenario-tailored Opioid Messaging Program (STOMP): An Interactive Intervention to Prevent Opioid-related Adverse Drug Events in Children and Adolescents

University of Michigan·interventional·Posted Sep 19, 2017·Updated Nov 19, 2020

In Brief

A clinical study evaluating Educational Intervention and Nudge for Pain, Postoperative and 4 related conditions. Completed, enrolled 712 participants across 1 site.

Detailed Summary

Millions of children and adolescents are prescribed opioid pain relievers each year, placing them at risk for serious adverse events and misuse in the home setting. Parents who manage these medicines, therefore, need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief for their children. The proposed research will evaluate new strategies to help parents learn about opioid risks, make safe and effective analgesic decisions, and develop and demonstrate safe drug management behaviors. 840 parents and their children who are undergoing an elective surgical procedure will be recruited. Parents will be randomized to receive the new educational and practical behavioral strategy or routine information. Parents' knowledge and perceptions will be evaluated at baseline and at critical times after surgery. Parents' opioid handling and administration will also be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 19, 2017
Enrollment StartOct 24, 2017
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.8 years ago

Interventions

Educational Interventionbehavioral

This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.

Nudgebehavioral

Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids