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OpenTrials
Completed

NCT Number: NCT03223246

Medication Education for Dosing Safety

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.

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Key information

Conditions

Pain Body Temperature Changes Fever Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Additional teaching

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days

    Time frame: 5-7 days

    Number of participants reporting dosing within 20% of the weight-based dose for the child at 5-7 days

  2. Number of Participants Reporting Contact With Other Providers at 48-72 Hours

    Time frame: 48-72 hours

    Number of participants reporting visit to primary care or emergency department providers at 48-72 hours

  3. Number of Participants Reporting Contact With Other Providers at 5-7 Days

    Time frame: 5-7 days

    Number of participants reporting visit to primary care or emergency department providers at 5-7 days.

Other outcomes

  1. Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours

    Time frame: 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).

  2. Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: MEDS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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