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N/A N=149 Randomized Double-blind Health Services Research

Medication Education for Dosing Safety

Pain · Fever

Enrolled (actual)
149
Serious AEs
2.7%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants Reporting Safe Dosing at 48-72 Hours — 28; 25 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Additional teaching (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Reporting Safe Dosing at 48-72 Hours
28; 25
SECONDARY
Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days
22; 26
SECONDARY
Number of Participants Reporting Contact With Other Providers at 48-72 Hours
29; 18
SECONDARY
Number of Participants Reporting Contact With Other Providers at 5-7 Days
23; 16

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03223246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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