NCT05344118

Brief Summary

This study involves an anonymous survey given to parents regarding their perceptions on prescription opioid use for pain control in children undergoing orthopedic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 25, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

April 19, 2022

Results QC Date

June 29, 2023

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Comfort With Child Receiving Opioids During Surgery

    Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) during surgery?

    Baseline

  • Comfort With Child Receiving Opioids After Surgery

    Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) after surgery?

    Baseline

  • Danger of Opioids

    Do you believe prescription opioids are dangerous?

    Baseline

  • Opioid Education

    How much education have you received about opioids?

    Baseline

  • Safe Storage of Opioids

    In your opinion, what is the most appropriate way to safely store opioids?

    Baseline

  • Safe Disposal of Opioids

    In your opinion, what is the most appropriate way to safely dispose of opioids?

    Baseline

Secondary Outcomes (4)

  • Employment Status

    Baseline

  • Education

    Baseline

  • Gender of Child

    Baseline

  • Age of Child

    Baseline

Study Arms (1)

Parents

Parents of children undergoing orthopedic surgery

Other: Survey

Interventions

SurveyOTHER

REDCap survey

Parents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parents of children scheduled for orthopedic surgery

You may qualify if:

  • Parents of patients between 1-18 years of age scheduled for orthopedic surgery at Nationwide Children's Hospital.

You may not qualify if:

  • Parents with children less than 1 or greater than 18 years of age or scheduled for surgery other than orthopedic.
  • Non-English speaking parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Limitations and Caveats

The study had a relatively small sample size with limited heterogeneity of respondents which could have led to a lack of differences among specific demographic, educational, and socioeconomic groups. The study also limited enrollment to English speakers so that they could easily complete the survey on the iPad. As such, this may not be representative of the diversity that is present in our entire parent population.

Results Point of Contact

Title
Dr. Joseph D Tobias
Organization
Nationwide Children's Hospital

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

March 25, 2022

Primary Completion

July 18, 2022

Study Completion

July 18, 2022

Last Updated

June 28, 2024

Results First Posted

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations