AnesthesiaNCT05353036

Survey to Identify Substance Use in Teenagers and Adolescents

An observational study of Anesthesia, 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.

Official record

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Trial summary

Who is it for?: Ages 12 to 21 years
Conditions the study is for: Anesthesia
What is being tested?: Survey
How many people: 250 participants
Where: 1 siteUnited States
Study dates: 27 May 2022to 15 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 12 to 21 years
All sexes
No healthy volunteers
Child, Adult

Study population: Adolescents undergoing procedure requiring anesthesia at Nationwide Children's Hospital.

Who may be able to join

Patients 12-21 years of age
Presenting for surgery or procedure requiring anesthesia

Who cannot join

Patients who are not able to complete the computerized survey due to physical or intellectual impairment
Patients who are non-English speaking

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: Expanded Preoperative Survey During Perioperative Care to Identify Substance Use in Teenagers and Adolescents

This is a prospective survey study of patients 12-21 years undergoing anesthetic care. The primary objective is to determine the incidence of illicit substance use and abuse prior to anesthetic care. The secondary objective is to determine the illicit substances used and their frequency in patients presenting for anesthetic care.

Read the detailed description

The participants will be asked to complete a survey in REDCap using an iPad during the visit. The study will record any positive answers from the drug and tobacco use questions routinely asked of the parents during the on-line pre-admission testing process. These include yes/no answers regarding drug, alcohol, and tobacco use.

The information collected will include only demographic data including age, weight, gender, ethnicity/race, and zip code. Survey data will be coded and will not include patient information. Completion of the survey will take approximately 15-20 minutes.

Conditions: Anesthesia
Being tested: Survey

What participants receive

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

SurveyOther
Survey assessing incidence, frequency, and type of illicit substance use

Study groups in NCT05353036
Study group	Role	What they receive
Adolescents		Patients 12-21 years undergoing anesthetic care Receives: Other: Survey

What is being measured

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

Number of Participants With Adolescent and Parent Reported Alcohol, Drug, Vaping and Tobacco Usage
As part of standard of care, nurses contact the parents of children scheduled for surgery to obtain health history and any alcohol, drug, vaping and tobacco usage. For the study, adolescents were asked to complete a survey on REDCap regarding their alcohol, drug, vaping and tobacco usage and those responses were compared to the answers the parents gave to the nurses during pre-op phone call.
Measured: Baseline
Alcohol Use
Adolescents were asked in a REDCap survey Do you currently or have you ever drank alcohol?
Measured: Baseline
Marijuana Use
Adolescents were asked in a REDCap survey Do you currently or have you ever smoked or consumed marijuana, THC, or cannabis?
Measured: Baseline
Vape Pen Use
Adolescents were asked in a REDCap survey Do you currently or have you ever vaped?
Measured: Baseline
Tobacco Use
Adolescents were asked in a REDCap survey Do you currently or have you ever used tobacco?
Measured: Baseline
Prescription Opioid Use for Acute Pain
Adolescents were asked in a REDCap survey Do you currently or have you ever used a prescribed opioid for acute pain?
Measured: Baseline

Secondary outcomes (11)

Most Recent Alcohol Use
Adolescents were asked in a REDCap survey When was the last time you used alcohol?
Measured: Baseline
Age First Drank Alcohol
Adolescents were asked in a REDCap survey How old were you when you first drank alcohol?
Measured: Baseline
Most Recent Marijuana Use
Adolescents were asked in a REDCap survey When was the last time you used marijuana?
Measured: Baseline
Age First Used Marijuana
Adolescents were asked in a REDCap survey How old were you when you first started using?
Measured: Baseline
Most Recent Vape Pen Use
Adolescents were asked in a REDCap survey When was the last time you vaped?
Measured: Baseline
Age First Started Vaping
Adolescents were asked in a REDCap survey How old were you when you first started vaping?
Measured: Baseline
Most Recent Tobacco Use
Adolescents were asked in a REDCap survey When was the last time you used tobacco?
Measured: Baseline
Age First Used Tobacco
Adolescents were asked in a REDCap survey How old were you when you started using tobacco?
Measured: Baseline
Most Recent Prescribed Opioid Use
Adolescents were asked in a REDCap survey When was the last time you used a prescribed opioid for acute pain?
Measured: Baseline
Prescribed Opioid Use for Anything Other Than Pain
Adolescents were asked in a REDCap survey Did you ever use that medication (prescribed opioid) for anything other than pain?
Measured: Baseline
Prescribed Opioid Use Leading to Abuse
Adolescents were asked in a REDCap survey Did your using prescribed opioid for anything other than pain lead to your abusing opioids/narcotics?
Measured: Baseline

Timeline

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

27 May 202215 Jul 2022

First posted29 Apr 2022
Study start27 May 2022
Primary completion15 Jul 2022
Study completion15 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 AnesthesiaStudies of the same condition, open and under way.
More trials run by Nationwide Children's HospitalThe 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: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05353036
Sponsor's protocol ID: STUDY00002306
Status last verified: Jun 2024
First submitted: 25 Apr 2022
Last updated: 26 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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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Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Expanded Preoperative Survey During Perioperative Care to Identify Substance Use in Teenagers and Adolescents
ClinicalTrials.gov ID: NCT05353036
Acronym / sponsor ID: STUDY00002306
Conditions: Anesthesia
Study type: Observational
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Nationwide Children's HospitalUniversity, hospital or other
Study start: 27 May 2022 (actual)
Primary completion: 15 Jul 2022 (actual)
Study completion: 15 Jul 2022 (actual)
First posted: 29 Apr 2022 (actual)
Results: Posted 26 Sep 2024

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Adolescents	–	Other: SurveyPatients 12-21 years undergoing anesthetic care

Who may qualify

Ages: 12 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Adolescents undergoing procedure requiring anesthesia at Nationwide Children's Hospital.

Key inclusion criteria (2 listed)

Patients 12-21 years of age
Presenting for surgery or procedure requiring anesthesia

Key exclusion criteria (2 listed)

Patients who are not able to complete the computerized survey due to physical or intellectual impairment
Patients who are non-English speaking

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
SurveySurvey assessing incidence, frequency, and type of illicit substance use	Other	Adolescents

Primary outcome

Number of Participants With Adolescent and Parent Reported Alcohol, Drug, Vaping and Tobacco Usage
Time frame: Baseline
As part of standard of care, nurses contact the parents of children scheduled for surgery to obtain health history and any alcohol, drug, vaping and tobacco usage. For the study, adolescents were asked to complete a survey on REDCap regarding their alcohol, drug, vaping and tobacco usage and those responses were compared to the answers the parents gave to the nurses during pre-op phone call.
Alcohol Use
Time frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever drank alcohol?
Marijuana Use
Time frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever smoked or consumed marijuana, THC, or cannabis?
Vape Pen Use
Time frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever vaped?
Tobacco Use
Time frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever used tobacco?
Prescription Opioid Use for Acute Pain
Time frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever used a prescribed opioid for acute pain?

11 secondary outcomes

Most Recent Alcohol Use
Time frame: Baseline
Age First Drank Alcohol
Time frame: Baseline
Most Recent Marijuana Use
Time frame: Baseline
Age First Used Marijuana
Time frame: Baseline
Most Recent Vape Pen Use
Time frame: Baseline
Age First Started Vaping
Time frame: Baseline
Most Recent Tobacco Use
Time frame: Baseline
Age First Used Tobacco
Time frame: Baseline
Most Recent Prescribed Opioid Use
Time frame: Baseline
Prescribed Opioid Use for Anything Other Than Pain
Time frame: Baseline
Prescribed Opioid Use Leading to Abuse
Time frame: Baseline

Results and safety

Results posted to the registry on 26 Sep 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
Adolescents	250	250

Primary outcome: Number of Participants With Adolescent and Parent Reported Alcohol, Drug, Vaping and Tobacco Usage

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

Measure	Overall n = 500	Adolescents n = 250	Parents n = 250
Alcohol: No response recorded	1	1	0
Alcohol: No	425	180	245
Alcohol: Yes	74	69	5
Drug use: No	437	198	239
Drug use: Yes	63	52	11
Vaping: No response recorded	1	1	0
Vaping: No	448	209	239
Vaping: Yes	51	40	11

Primary outcome: Alcohol Use

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

Measure	Adolescents n = 250
No response recorded	1
No	180
Yes	69

Primary outcome: Marijuana Use

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

Measure	Adolescents n = 250
No response recorded	1
No	198
Yes	51

Primary outcome: Vape Pen Use

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

Measure	Adolescents n = 250
No response recorded	1
No	209
Yes	40

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adolescents	0 of 250 (0%)	0 of 250 (0%)	0 of 250

Limitations and caveats (from the sponsor): One of the limitations of this study is the fact that data were only collected during the summer months. It is possible that these data would differ if collected throughout the school year. Additionally, the surveys were collected from patients undergoing prescheduled surgical procedures. Due to the rapid nature of urgent or emergent cases, inclusion of these patients in the study cohort was not deemed feasible.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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 Anesthesia, 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 2 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 26 Sep 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 26 Sep 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?

Number of Participants With Adolescent and Parent Reported Alcohol, Drug, Vaping and Tobacco Usage (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 NCT05353036.

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 26 Sep 2024.