Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents

Completed · Not applicable

Conditions studied: Pain, Postoperative, Medication Adherence, Opioid Use, Knowledge, Attitudes, Practice, Risk Reduction Behavior

In brief

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.

Key facts

Study ID

NCT03287622

Run by

University of Michigan

People needed

712

Starts

2017-10-24

Expected to finish

2019-09-30

Last updated by the study team

2020-11-19

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parent (>=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an opioid for postoperative pain management
• English speaking

You may not qualify if…

• Child is undergoing a non-elective procedure
• Child cannot self-report pain levels (i.e., is cognitively impaired)
• Child has a hematologic/oncologic condition
• Child has a kidney or liver conditions that precludes the usual analgesic prescription pattern (opioid plus a non-opioid)
• Child has been taking opioids for prolonged pain pre-operatively (>2 weeks)

Where it is running

• University of Michigan, C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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