NCT03562013

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

June 7, 2018

Last Update Submit

October 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Questionnaire on Opioid use

    Questionnaire on how families provide adequate and safe pain management at home

    28 days following discharge from hospital

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 29215370BACKGROUND
  • 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.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Conor Mc Donnell, MD

    Staff Anesthesiologist

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 7, 2018

First Posted

June 19, 2018

Study Start

July 18, 2018

Primary Completion

March 29, 2019

Study Completion

July 31, 2019

Last Updated

October 11, 2019

Record last verified: 2019-10

Locations