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.

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.

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.

Clinical Trials on Pain Management

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