Orthopedic DisorderNCT05344118

Parental Perceptions on Prescription Opioid Use

An observational study of Orthopedic Disorder, run by Nationwide Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Orthopedic Disorder
What is being tested?: Survey
How many people: 125 participants
Where: 1 siteUnited States
Study dates: 25 Mar 2022to 18 Jul 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Parents of children scheduled for orthopedic surgery

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: Parental Perceptions on Prescription Opioid Use for Pain Control in Children Undergoing Orthopedic Surgery

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

Conditions: Orthopedic Disorder
Being tested: Survey
Medical subject headings: Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurveyOther
REDCap survey

Study groups in NCT05344118
Study group	Role	What they receive
Parents		Parents of children undergoing orthopedic surgery Receives: Other: Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

Comfort With Child Receiving Opioids During Surgery
Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) during surgery?
Measured: Baseline
Comfort With Child Receiving Opioids After Surgery
Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) after surgery?
Measured: Baseline
Danger of Opioids
Do you believe prescription opioids are dangerous?
Measured: Baseline
Opioid Education
How much education have you received about opioids?
Measured: Baseline
Safe Storage of Opioids
In your opinion, what is the most appropriate way to safely store opioids?
Measured: Baseline
Safe Disposal of Opioids
In your opinion, what is the most appropriate way to safely dispose of opioids?
Measured: Baseline

Secondary outcomes (4)

Employment Status
Current employment status of parent
Measured: Baseline
Education
Level of education of parent
Measured: Baseline
Gender of Child
Gender at birth of participant's child undergoing surgery
Measured: Baseline
Age of Child
Age of the participant's child undergoing surgery
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 202218 Jul 2022

First posted25 Apr 2022
Study start25 Mar 2022
Primary completion18 Jul 2022
Study completion18 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
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: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05344118
Sponsor's protocol ID: STUDY00002410
Status last verified: Jun 2024
First submitted: 19 Apr 2022
Last updated: 28 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Orthopedic Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Parental Perceptions on Prescription Opioid Use for Pain Control in Children Undergoing Orthopedic Surgery
ClinicalTrials.gov ID: NCT05344118
Acronym / sponsor ID: STUDY00002410
Conditions: Orthopedic Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Nationwide Children's HospitalUniversity, hospital or other
Study start: 25 Mar 2022 (actual)
Primary completion: 18 Jul 2022 (actual)
Study completion: 18 Jul 2022 (actual)
First posted: 25 Apr 2022 (actual)
Results: Posted 28 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Parents	–	Other: SurveyParents of children undergoing orthopedic surgery

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Parents of children scheduled for orthopedic surgery

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SurveyREDCap survey	Other	Parents

Primary outcome

Comfort With Child Receiving Opioids During Surgery
Time frame: Baseline
Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) during surgery?
Comfort With Child Receiving Opioids After Surgery
Time frame: Baseline
Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) after surgery?
Danger of Opioids
Time frame: Baseline
Do you believe prescription opioids are dangerous?
Opioid Education
Time frame: Baseline
How much education have you received about opioids?
Safe Storage of Opioids
Time frame: Baseline
In your opinion, what is the most appropriate way to safely store opioids?
Safe Disposal of Opioids
Time frame: Baseline
In your opinion, what is the most appropriate way to safely dispose of opioids?

4 secondary outcomes

Employment Status
Time frame: Baseline
Education
Time frame: Baseline
Gender of Child
Time frame: Baseline
Age of Child
Time frame: Baseline

Results and safety

Results posted to the registry on 28 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parents	125	125

Primary outcome: Comfort With Child Receiving Opioids During Surgery

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Parents n = 125
No	5
Yes	84
Yes, but I have concerns	36

Primary outcome: Comfort With Child Receiving Opioids After Surgery

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Parents n = 125
No	11
Yes	69
Yes, but I have concerns	45

Primary outcome: Danger of Opioids

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Parents n = 122
No	41
Yes	81

Population analysed: Three of the 125 participants did not answer this question.

Primary outcome: Opioid Education

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Parents n = 125
None	12
Somewhat informed	68
Very informed	45

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parents	0 of 125 (0%)	0 of 125 (0%)	0 of 125

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Orthopedic Disorder

Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
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Not yet recruiting
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Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Kinesitherapy Plus Osteopathy After Surgery for Dupuytren Disease
Dupuytren Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Orthopedic Disorder, run by Nationwide Children's Hospital at 1 site in United States.

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 1 inclusion and 2 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 28 Jun 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comfort With Child Receiving Opioids During Surgery (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT05344118.

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 28 Jun 2024.