Trial Outcomes & Findings for Parental Perceptions on Prescription Opioid Use (NCT NCT05344118)

NCT ID: NCT05344118

Last Updated: 2024-06-28

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 125 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2024-06-28

Participant Flow

Participant milestones

Measure	Parents Parents of children undergoing orthopedic surgery Survey: REDCap survey
Overall Study STARTED	125
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data not collected via survey

Baseline characteristics by cohort

Measure	Parents n=125 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Age, Customized	0 Participants Age data not collected via survey
Sex/Gender, Customized	0 Participants Sex/gender data not collected via survey
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=125 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	117 Participants n=125 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=125 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=125 Participants
Race (NIH/OMB) Asian	2 Participants n=125 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=125 Participants
Race (NIH/OMB) Black or African American	13 Participants n=125 Participants
Race (NIH/OMB) White	103 Participants n=125 Participants
Race (NIH/OMB) More than one race	3 Participants n=125 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=125 Participants
Relationship to child Father	26 Participants n=123 Participants • 2 of the participants did not answer this question in the survey.
Relationship to child Grandparent	5 Participants n=123 Participants • 2 of the participants did not answer this question in the survey.
Relationship to child Legal Guardian	4 Participants n=123 Participants • 2 of the participants did not answer this question in the survey.
Relationship to child Mother	88 Participants n=123 Participants • 2 of the participants did not answer this question in the survey.
Marital Status Divorced or separated	16 Participants n=125 Participants
Marital Status Married or domestic partner	81 Participants n=125 Participants
Marital Status Single, never married	25 Participants n=125 Participants
Marital Status No answer	3 Participants n=125 Participants
Primary Language Spoken at Home English	118 Participants n=125 Participants
Primary Language Spoken at Home Other	2 Participants n=125 Participants
Primary Language Spoken at Home No answer	5 Participants n=125 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Parents n=125 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Comfort With Child Receiving Opioids During Surgery No	5 Participants
Comfort With Child Receiving Opioids During Surgery Yes	84 Participants
Comfort With Child Receiving Opioids During Surgery Yes, but I have concerns	36 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Parents n=125 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Comfort With Child Receiving Opioids After Surgery No	11 Participants
Comfort With Child Receiving Opioids After Surgery Yes	69 Participants
Comfort With Child Receiving Opioids After Surgery Yes, but I have concerns	45 Participants

PRIMARY outcome

Timeframe: Baseline

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

Do you believe prescription opioids are dangerous?

Outcome measures

Measure	Parents n=122 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Danger of Opioids No	41 Participants
Danger of Opioids Yes	81 Participants

PRIMARY outcome

Timeframe: Baseline

How much education have you received about opioids?

Outcome measures

Measure	Parents n=125 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Opioid Education None	12 Participants
Opioid Education Somewhat informed	68 Participants
Opioid Education Very informed	45 Participants

PRIMARY outcome

Timeframe: Baseline

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

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

Outcome measures

Measure	Parents n=122 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Safe Storage of Opioids Don't know	2 Participants
Safe Storage of Opioids In a locked place	70 Participants
Safe Storage of Opioids Medicine cabinet	5 Participants
Safe Storage of Opioids Out of reach of children	45 Participants

PRIMARY outcome

Timeframe: Baseline

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

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

Outcome measures

Measure	Parents n=123 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Safe Disposal of Opioids Throw them in the garbage	1 Participants
Safe Disposal of Opioids Don't know	6 Participants
Safe Disposal of Opioids Drop them in a disposal box	25 Participants
Safe Disposal of Opioids Flush them down the sink/disposal/toilet	16 Participants
Safe Disposal of Opioids Take them to a collection event	30 Participants
Safe Disposal of Opioids Take them to a pharmacy, doctor, or hospital	45 Participants

SECONDARY outcome

Timeframe: Baseline

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

Current employment status of parent

Outcome measures

Measure	Parents n=122 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Employment Status Employed for wages	85 Participants
Employment Status Not working	8 Participants
Employment Status Out of work and looking for work	2 Participants
Employment Status Self-employed	12 Participants
Employment Status Stay at home parent	14 Participants
Employment Status Student	1 Participants

SECONDARY outcome

Timeframe: Baseline

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

Level of education of parent

Outcome measures

Measure	Parents n=121 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Education Advanced degree	23 Participants
Education Bachelor's degree	16 Participants
Education Between high school and college	58 Participants
Education High school graduate, diploma, or equivalent	21 Participants
Education Some high school, no diploma	3 Participants

SECONDARY outcome

Timeframe: Baseline

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

Gender at birth of participant's child undergoing surgery

Outcome measures

Measure	Parents n=123 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Gender of Child Female	63 Participants
Gender of Child Male	60 Participants

SECONDARY outcome

Timeframe: Baseline

Age of the participant's child undergoing surgery

Outcome measures

Measure	Parents n=125 Participants Parents of children undergoing orthopedic surgery Survey: REDCap survey
Age of Child	11.3 years Standard Deviation 4.2

Adverse Events

Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph D Tobias

Nationwide Children's Hospital

Phone: 614-722-4200

Email: joseph.tobias@nationwidechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place