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Clinical Trials/NCT02814305
NCT02814305CompletedNot Applicable

Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

University of Pennsylvania0 sites79 target enrollmentStarted: March 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
79
Primary Endpoint
Unused opioids

Study Overview

Brief Summary

Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills.

Aims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery.

Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Non-institutionalized

Exclusion Criteria

  • pregnancy
  • a history of opioid analgesic misuse/abuse
  • ongoing participation in other clinical research
  • or daily use of opioid analgesics in the week prior to surgery

Outcomes

Primary Outcomes

Unused opioids

Time Frame: 21 days after surgery

Number of opioids reported unused by the patient after postoperative day 21

Secondary Outcomes

  • Intent to dispose of opioids(Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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