Pain Management Clinical Trial
Official title:
Family Experience of Home Opioid Use After Pediatric Surgery: a Pilot Study
| NCT number | NCT03562013 |
| Other study ID # | 1000060801 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 18, 2018 |
| Est. completion date | July 31, 2019 |
| Verified date | October 2019 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
A systematic review examining outpatient opioid use identified only three pediatric studies published between 2015 and 2016. Of these three, two studies had a short-term follow up with patients at three days after discharge; moreover, these three studies were limited by focusing on one surgical population, restriction of data to 0-12 yr old participants, and the other being a brief report. As a result, there are no pediatric studies that have examined opioid use amongst 0-18 yr olds, across multiple surgery types, and beyond 3 days after discharge.
| Status | Completed |
| Enrollment | 89 |
| Est. completion date | July 31, 2019 |
| Est. primary completion date | March 29, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
Inclusion Criteria: - Families are filling a prescription for opioid medications at Shoppers Drug Mart at The Hospital for Sick Children - Parent has strong command of the English language (i.e., no interpreter required) Exclusion Criteria: - Child has used opioid medication at home within 6 months before the date of their surgical procedure - Child has history of chronic pain - Child is being discharged to a rehabilitation facility anticipated |
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children |
Canada,
Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Questionnaire on Opioid use | Questionnaire on how families provide adequate and safe pain management at home | 28 days following discharge from hospital |
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