Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair

NCT04059055 | Completed

• 1 other identifier: 1000064960
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Over the past two decades, the misuse of prescription opioids has significantly increased. A recent systematic review reported as much as 67% to 92% of opioids dispensed on discharge post-surgery go unused. This culture of overprescribing is consistently observed across surgical specialties. Less frequently observed is the potential for opioid use and misuse in children and adolescents post-surgery. The research to date in this area has been poorly performed with heterogenous data collection, analysis and reporting, as well as large loss of patients to follow-up. The investigators' previous prospective observational deception study identified three areas of concern:

1. 1.There is a culture of postoperative opioid over-prescribing at discharge as demonstrated by heterogenous opioid dosing and duration of treatments across practitioners for single procedures
2. 2.This overprescribing is in excess of patients' home-requirements and results in significant quantities of leftover opioids
3. 3.There is a culture of inappropriate storage and lack of safe disposal of prescribed opioids in the community

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain medication use questionnaire

  Recording of how many pain meds were used at home

  3 days following discharge from hospital

Secondary Outcomes (1)

• Amount of opioid returned

  3 weeks following discharge (aligns with pin/wire removal at fracture clinic)

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Any child (0-18 years) who has undergone a supracondylar fracture repair at The Hospital for Sick Children.

You may qualify if:

• Patients with supracondylar fractures undergoing surgical wire placement or pinning that return to fracture clinic at three weeks for removal of pins/wires.
• Patients discharged on the weekday.
• Families filling a prescription for opioids at Shoppers Drug Mart at SickKids Hospital.
• Parent has strong command of the English language (i.e., no interpreter required).

You may not qualify if:

• Patients with a history of chronic pain.
• Patient used opioid medication within the previous 6 months.
• Patients who are discharged on the weekend (as participant emails will need to be entered into redcap the day of recruitment, for data collection to commence the next morning).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Conor Mc Donnell

  Staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: October 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

CA (1)