NCT05353036

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 26, 2024

Completed
Last Updated

September 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

April 25, 2022

Results QC Date

July 5, 2023

Last Update Submit

June 6, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    Baseline

  • Alcohol Use

    Adolescents were asked in a REDCap survey Do you currently or have you ever drank alcohol?

    Baseline

  • Marijuana Use

    Adolescents were asked in a REDCap survey Do you currently or have you ever smoked or consumed marijuana, THC, or cannabis?

    Baseline

  • Vape Pen Use

    Adolescents were asked in a REDCap survey Do you currently or have you ever vaped?

    Baseline

  • Tobacco Use

    Adolescents were asked in a REDCap survey Do you currently or have you ever used tobacco?

    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?

    Baseline

Secondary Outcomes (11)

  • Most Recent Alcohol Use

    Baseline

  • Age First Drank Alcohol

    Baseline

  • Most Recent Marijuana Use

    Baseline

  • Age First Used Marijuana

    Baseline

  • Most Recent Vape Pen Use

    Baseline

  • +6 more secondary outcomes

Study Arms (1)

Adolescents

Patients 12-21 years undergoing anesthetic care

Other: Survey

Interventions

SurveyOTHER

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

Adolescents

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

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

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.

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, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

May 27, 2022

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

September 26, 2024

Results First Posted

September 26, 2024

Record last verified: 2024-06

Locations