Medication Education for Dosing Safety

Pain Clinical Trial

— MEDS  

Official title:

Medication Education for Dosing Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223246
• Other study ID #: 2017P001482
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: August 28, 2018

Study information

• Verified date: October 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fever
• Pain

Intervention

Other:
• Additional teaching
A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours	Number of participants reporting dosing error is above and/or below the weight-based dose for the child. Correct dosing was defined as 10mg/kg for ibuprofen and 10-15mg/kg for acetaminophen; dosing was considered incorrect if more than 20% above or below these values. Participants could be counted in more than one category for this outcome if they made more than one type of mistake (i.e. reported dose too high for acetaminophen and too low for ibuprofen).	48-72 hours
Other	Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days	Number of participants reporting dosing error is above and/or below the weight-based dose for the child. Correct dosing was defined as 10mg/kg for ibuprofen and 10-15mg/kg for acetaminophen; dosing was considered incorrect if more than 20% above or below these values. Participants could be counted in more than one category for this outcome if they made more than one type of mistake (i.e. reported dose too high for acetaminophen and too low for ibuprofen).	5-7 days
Primary	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	48-72 hours
Secondary	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	5-7 days
Secondary	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	48-72 hours
Secondary	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.	5-7 days