Opioid Use, UnspecifiedNCT04219397
Investigating Interventions to Reduce Residual Opioids in the Home Following Legitimate Opioid Prescribing in Children.
A study testing Medication take back and Medication home disposal in people with Opioid Use, Unspecified, run by Indiana University at 2 sites in United States.
Trial summary
The overall objective of this study is to evaluate strategies to reduce unused opioids prescribed for pediatric acute post-surgical pain management. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Unspecified
- What is being tested?
- Medication take back and Medication home disposal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2020to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female children ages 12-17.9 years old
- ASA physical status 1 and 2
- Patients undergoing primary posterior spinal fusion surgery for correction of idiopathic scoliosis.
- Patients undergoing Nuss bar correction of pectus excavatum deformity.
Who cannot join
- Oxycodone allergy
- severe sleep apnea
- developmental delay
- neurological disorders
- liver disease/impairment
- renal disease/decreased renal function
- patients on opioid therapy prior to surgery
- Requires a translator for communication in English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Riley Hospital for Children/Indiana University
Indianapolis, Indiana, 46202
Children's Hospital of New Orleans/ LCMC Health
New Orleans, Louisiana, 70118
About this study
Official title: Investigating the Impact of Formal Interventions on Reducing Residual Opioids in the Home Following Legitimate Prescribing for Acute Post-surgical Pain in Pediatric Patients.
The overall objective of this study is to evaluate strategies to reduce unused opioids prescribed for pediatric acute post-surgical pain management.
Read the detailed description
Prescription opioids are abused by an estimated 12.5 million Americans, and accidental opioid overdose is the leading cause of injury death in the US. Many of these drugs originate from leftover prescription opioids related to postoperative overprescribing, lack of proper disposal, and unsafe home storage. Governmental guidelines indicate that leftover prescription opioids should be preferentially returned to a drug take back site; however, many people do not utilize these programs due to travel distance, lack of transportation, or other factors.
The aims are to quantify the amount of unused opioids in the home following painful pediatric surgical procedures, investigate the impact of formal interventions on disposal of residual opioids in the home following these surgeries, and to identify current behaviors of adolescents and their family members in the handling of unused prescribed opioids.
- Conditions
- Opioid Use, Unspecified
- Being tested
- Medication take back, Medication home disposal
- Keywords
- opioid stewardship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication take backOther
Patients will be provided with formal education about medication take back programs for left-over prescription medications. They will be provided with directions to the closest medication take back facility to their home, and directions to the closet medication take back facility near their post-operative clinic site, and instructed to dispose of any left-over oxycodone medication (at completion of analgesic therapy) through participating in medication take back.
Medication home disposalOther
Patients and their families will be provided with formal education about how to use the medication home disposal kit: Dispose Rx, provided with a Dispose Rx home disposal kit, and instructed to dispose of any left-over oxycodone prescription medications with this kit following completion of analgesic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol. There will be no interventions provided. They will receive a follow up phone call survey and be asked to return a completed medication education calendar that is provided as a part of usual APS care. |
| Medication take back education intervention | Experimental | Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol as described in the control group. They will receive a standardized education intervention. This intervention will educate patients and their families about medication take back programs, and will provide tailored directions to the closest medication take back center from their home, and also an option for medication take back that is located in close proximity to Riley Hospital clinics. Receives: Other: Medication take back |
| Home disposal kit intervention | Experimental | Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol as described in the control group. They will receive standardized education about how to use the medication home disposal kit : Dispose Rx(r), and they will be instructed to use this kit to dispose of any left over opioid medications that they may have after they have competed therapy for pain management at home. Receives: Other: Medication home disposal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of residual opioids.
Identify if there are left over opioid medications following completion of analgesic therapy, and if so, how many?
Measured: Post-discharge days 8-10
Assess participation in medication take back through follow up phone interview questionnaire.
Assess the degree of participation in medication take back programs to dispose of any residual opioid medications following completion of analgesic therapy.
Measured: Post-discharge days 8-10
Assess participation in medication home disposal through follow up phone interview questionnaire.
Assess the degree of participation in medication home disposal to dispose of any residual opioid medications following completion of analgesic therapy.
Measured: Post-discharge days 8-10
Secondary outcomes (3)
Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire.
Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids despite formal education to patients/families about medication take back and medication home disposal of residual medications at the completion of analgesic therapy.
Measured: Post-discharge days 8-10
Average daily pain scores reported as values on Numerical Rating Scale.
Assess average daily pain scores for patients undergoing painful surgeries in the perioperative period and following discharge from the hospital. This will be obtained through numerical report on study specific calendar. Numerical values are reported as a minimum of zero and a maximum of 10 on the Numerical Rating Scale. 0 corresponds with no pain, 1 with lower pain, and 10 corresponds with the most severe pain.
Measured: Preoperatively through post-discharge day #10
Frequency of opioid consumption through follow up phone interview questionnaire.
Assess the frequency of daily oxycodone consumption and correlate consumption with self reported pain scores. This measure will ask for a self-reported numerical frequency of daily opioid medication use. When this medication is used, we ask patients to rate their pain on the Numerical rating Scale from 0 to 10. Zero corresponds with no pain, 10 corresponds with the most severe pain.
Measured: Post-operative day 1 through post-discharge day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start23 Jan 2020
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Usual care (control) 2. Intervention #1: provision of formal education on medication take back 3. Intervention #2: provision of formal education on medication home disposal of residual opioids, and provision of a medication home disposal kit.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- The Society for Pediatric Anesthesia, LCMC Health
- Responsible party
- Sponsor
- Investigators
- Michele A Hendrickson, MD,MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219397
- Sponsor's protocol ID
- 1905175369
- Status last verified
- Feb 2024
- First submitted
- 13 Dec 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Formal Interventions on Reducing Residual Opioids in the Home Following Legitimate Prescribing for Acute Post-surgical Pain in Pediatric Patients.
- ClinicalTrials.gov ID
- NCT04219397
- Acronym / sponsor ID
- 1905175369
- Conditions
- Opioid Use, Unspecified
- Keywords
- opioid stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- The Society for Pediatric Anesthesia, LCMC Health
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to evaluate strategies to reduce unused opioids prescribed for pediatric acute post-surgical pain management.
Detailed description
Prescription opioids are abused by an estimated 12.5 million Americans, and accidental opioid overdose is the leading cause of injury death in the US. Many of these drugs originate from leftover prescription opioids related to postoperative overprescribing, lack of proper disposal, and unsafe home storage. Governmental guidelines indicate that leftover prescription opioids should be preferentially returned to a drug take back site; however, many people do not utilize these programs due to travel distance, lack of transportation, or other factors.
The aims are to quantify the amount of unused opioids in the home following painful pediatric surgical procedures, investigate the impact of formal interventions on disposal of residual opioids in the home following these surgeries, and to identify current behaviors of adolescents and their family members in the handling of unused prescribed opioids.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. Usual care (control) 2. Intervention #1: provision of formal education on medication take back 3. Intervention #2: provision of formal education on medication home disposal of residual opioids, and provision of a medication home disposal kit.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol. There will be no interventions provided. They will receive a follow up phone call survey and be asked to return a completed medication education calendar that is provided as a part of usual APS care. |
| Medication take back education intervention | Experimental | Other: Medication take backPatients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol as described in the control group. They will receive a standardized education intervention. This intervention will educate patients and their families about medication take back programs, and will provide tailored directions to the closest medication take back center from their home, and also an option for medication take back that is located in close proximity to Riley Hospital clinics. |
| Home disposal kit intervention | Experimental | Other: Medication home disposalPatients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol as described in the control group. They will receive standardized education about how to use the medication home disposal kit : Dispose Rx(r), and they will be instructed to use this kit to dispose of any left over opioid medications that they may have after they have competed therapy for pain management at home. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female children ages 12-17.9 years old
- ASA physical status 1 and 2
- Patients undergoing primary posterior spinal fusion surgery for correction of idiopathic scoliosis.
- Patients undergoing Nuss bar correction of pectus excavatum deformity.
Key exclusion criteria (8 listed)
- Oxycodone allergy
- severe sleep apnea
- developmental delay
- neurological disorders
- liver disease/impairment
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 |
|---|---|---|
| Medication take backPatients will be provided with formal education about medication take back programs for left-over prescription medications. They will be provided with directions to the closest medication take back facility to their home, and directions to the closet medication take back facility near their post-operative clinic site, and instructed to dispose of any left-over oxycodone medication (at completion of analgesic therapy) through participating in medication take back. | Other | Medication take back education intervention |
| Medication home disposalPatients and their families will be provided with formal education about how to use the medication home disposal kit: Dispose Rx, provided with a Dispose Rx home disposal kit, and instructed to dispose of any left-over oxycodone prescription medications with this kit following completion of analgesic therapy. | Other | Home disposal kit intervention |
Primary outcome
Quantification of residual opioids.
Time frame: Post-discharge days 8-10
Identify if there are left over opioid medications following completion of analgesic therapy, and if so, how many?
Assess participation in medication take back through follow up phone interview questionnaire.
Time frame: Post-discharge days 8-10
Assess the degree of participation in medication take back programs to dispose of any residual opioid medications following completion of analgesic therapy.
Assess participation in medication home disposal through follow up phone interview questionnaire.
Time frame: Post-discharge days 8-10
Assess the degree of participation in medication home disposal to dispose of any residual opioid medications following completion of analgesic therapy.
3 secondary outcomes
Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire.
Time frame: Post-discharge days 8-10
Average daily pain scores reported as values on Numerical Rating Scale.
Time frame: Preoperatively through post-discharge day #10
Frequency of opioid consumption through follow up phone interview questionnaire.
Time frame: Post-operative day 1 through post-discharge day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Michele A Hendrickson, MD,MS principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication take back and Medication home disposal in people with Opioid Use, Unspecified, run by Indiana University at 2 sites 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 4 inclusion and 8 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of residual opioids. (time frame: Post-discharge days 8-10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2024.