- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562013
Family Experience of Home Opioid Use After Pediatric Surgery
October 9, 2019 updated by: Conor McDonnell, The Hospital for Sick Children
Family Experience of Home Opioid Use After Pediatric Surgery: a Pilot Study
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is being done to learn how long children (0-18 yrs) needed to use the prescribed opioid medication for and how families can be better prepared to provide adequate and safe pain management at home.
Follow up will take place 28 days after discharge from the hospital.
Study Type
Observational
Enrollment (Actual)
89
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Any child (0-18 years) who has undergone a surgical procedure at The Hospital for Sick Children within 7 days of discharge.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire on Opioid use
Time Frame: 28 days following discharge from hospital
|
Questionnaire on how families provide adequate and safe pain management at home
|
28 days following discharge from hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Conor Mc Donnell, MD, Staff Anesthesiologist
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Caldeira-Kulbakas M, Stratton C, Roy R, Bordman W, Mc Donnell C. A prospective observational study of pediatric opioid prescribing at postoperative discharge: how much is actually used? Can J Anaesth. 2020 Jul;67(7):866-876. doi: 10.1007/s12630-020-01616-5. Epub 2020 Mar 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2018
Primary Completion (Actual)
March 29, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
June 7, 2018
First Submitted That Met QC Criteria
June 7, 2018
First Posted (Actual)
June 19, 2018
Study Record Updates
Last Update Posted (Actual)
October 11, 2019
Last Update Submitted That Met QC Criteria
October 9, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1000060801
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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