Pain ManagementNCT03562013
Family Experience of Home Opioid Use After Pediatric Surgery
An observational study of Pain Management, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jul 2018to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Any child (0-18 years) who has undergone a surgical procedure at The Hospital for Sick Children within 7 days of discharge.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain Management
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on Opioid use
Questionnaire on how families provide adequate and safe pain management at home
Measured: 28 days following discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start18 Jul 2018
- Primary completion29 Mar 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conor McDonnell, The Hospital for Sick Children
- Investigators
- Conor Mc Donnell, MD, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562013
- Sponsor's protocol ID
- 1000060801
- Status last verified
- Oct 2019
- First submitted
- 7 Jun 2018
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29215370Caldeira-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.
PubMed 32166621
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Experience of Home Opioid Use After Pediatric Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT03562013
- Acronym / sponsor ID
- 1000060801
- Conditions
- Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Any child (0-18 years) who has undergone a surgical procedure at The Hospital for Sick Children within 7 days of discharge.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire on Opioid use
Time frame: 28 days following discharge from hospital
Questionnaire on how families provide adequate and safe pain management at home
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Background: PubMed 29215370Feinberg 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.
- Derived from this study: PubMed 32166621Caldeira-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conor Mc Donnell, MD principal investigator
Staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on Opioid use (time frame: 28 days following discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562013, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.