PainMEDSNCT03223246
Medication Education for Dosing Safety
A study testing Additional teaching in people with Pain and Fever, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Acetaminophen and ibuprofen are two of the most commonly used medication products among children <12 years old, and these medications are frequently prescribed for patients leaving the emergency department (ED), but previous studies have shown that parents often leave the ED unsure of how to safely dose these… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Additional teaching
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 28 Aug 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- parents of children between ages of 90 days to 11.9 years
- being discharged with a plan for use of liquid acetaminophen (any age) or ibuprofen (limited to those >6 months old). The clinical team will determine planned medication use.
- parental fluency in English or Spanish
- ability to be reached by telephone over the next 7 days
- planned discharge home.
Who cannot join
- presence of a complex chronic condition in the child
- planned use of a non-standard weight-based medication dose.
- Families will also be excluded if the adult with the child is not a parent or legal guardian.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Acetaminophen and ibuprofen are two of the most commonly used medication products among children <12 years old, and these medications are frequently prescribed for patients leaving the emergency department (ED), but previous studies have shown that parents often leave the ED unsure of how to safely dose these medications at home. This study will be a randomized controlled trial of a brief medication safety intervention, and examining parental knowledge and implementation of appropriate weight-based dosing.
- Being tested
- Additional teaching
- Medical subject headings
- Pain, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional teachingOther
A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Additional teaching | Experimental | Not described Receives: Other: Additional teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Safe Dosing at 48-72 Hours
Number of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours
Measured: 48-72 hours
Secondary outcomes (3)
Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days
Number of participants reporting dosing within 20% of the weight-based dose for the child at 5-7 days
Measured: 5-7 days
Number of Participants Reporting Contact With Other Providers at 48-72 Hours
Number of participants reporting visit to primary care or emergency department providers at 48-72 hours
Measured: 48-72 hours
Number of Participants Reporting Contact With Other Providers at 5-7 Days
Number of participants reporting visit to primary care or emergency department providers at 5-7 days.
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Oct 2017
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Samuels-Kalow, Massachusetts General Hospital
- Investigators
- Margaret Samuels-Kalow, MD MSHP, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223246
- Sponsor's protocol ID
- 2017P001482
- Acronym
- MEDS
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2017
- Last updated
- 4 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naureckas Li C, Camargo CA Jr, Faridi M, Espinola JA, Hayes BD, Porter S, Cohen A, Samuels-Kalow M. Medication Education for Dosing Safety: A Randomized Controlled Trial. Ann Emerg Med. 2020 Nov;76(5):637-645. doi: 10.1016/j.annemergmed.2020.07.007. Epub 2020 Aug 15.
PubMed 32807539
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Education for Dosing Safety
- ClinicalTrials.gov ID
- NCT03223246
- Acronym / sponsor ID
- MEDS / 2017P001482
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acetaminophen and ibuprofen are two of the most commonly used medication products among children <12 years old, and these medications are frequently prescribed for patients leaving the emergency department (ED), but previous studies have shown that parents often leave the ED unsure of how to safely dose these medications at home. This study will be a randomized controlled trial of a brief medication safety intervention, and examining parental knowledge and implementation of appropriate weight-based dosing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Additional teaching | Experimental | Other: Additional teaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- parents of children between ages of 90 days to 11.9 years
- being discharged with a plan for use of liquid acetaminophen (any age) or ibuprofen (limited to those >6 months old). The clinical team will determine planned medication use.
- parental fluency in English or Spanish
- ability to be reached by telephone over the next 7 days
- planned discharge home.
Key exclusion criteria (3 listed)
- presence of a complex chronic condition in the child
- planned use of a non-standard weight-based medication dose.
- Families will also be excluded if the adult with the child is not a parent or legal guardian.
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 |
|---|---|---|
| Additional teachingA brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding. | Other | Additional teaching |
Primary outcome
Number of Participants Reporting Safe Dosing at 48-72 Hours
Time frame: 48-72 hours
Number of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours
3 secondary outcomes
Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days
Time frame: 5-7 days
Number of Participants Reporting Contact With Other Providers at 48-72 Hours
Time frame: 48-72 hours
Number of Participants Reporting Contact With Other Providers at 5-7 Days
Time frame: 5-7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32807539Naureckas Li C, Camargo CA Jr, Faridi M, Espinola JA, Hayes BD, Porter S, Cohen A, Samuels-Kalow M. Medication Education for Dosing Safety: A Randomized Controlled Trial. Ann Emerg Med. 2020 Nov;76(5):637-645. doi: 10.1016/j.annemergmed.2020.07.007. Epub 2020 Aug 15.
- Individual participant dataSharing planned: No
Related trials for Pain
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
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.
Margaret Samuels-Kalow, MD MSHP principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional teaching in people with Pain and Fever, run by Massachusetts General 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 5 inclusion and 3 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 4 Nov 2020. 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 4 Nov 2020). 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 Reporting Safe Dosing at 48-72 Hours (time frame: 48-72 hours). 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 NCT03223246, which also lists 1 linked publication.
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 4 Nov 2020.