- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04059055
Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair
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:
- 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
- This overprescribing is in excess of patients' home-requirements and results in significant quantities of leftover opioids
- There is a culture of inappropriate storage and lack of safe disposal of prescribed opioids in the community
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain medication use questionnaire
Tidsramme: 3 days following discharge from hospital
|
Recording of how many pain meds were used at home
|
3 days following discharge from hospital
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Amount of opioid returned
Tidsramme: 3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
|
Recording of how much opioid was returned to the hospital
|
3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Conor Mc Donnell, Staff Anesthesiologist
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1000064960
Legemiddel- og utstyrsinformasjon, studiedokumenter
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