Pre-calculated Doses of Medication for Pediatric Resuscitation, a Simulation Experimental Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
Dosage errors are common in the stressful situation of a pediatric resuscitation. In addition to that, studies have reported that delays to provide medication is associated to worst survival rate for very sick children. To minimize delays and error, the investigators recently published a resuscitation handbook who provides drug dosages for each weight for children thus eliminating the need for dosage calculation. Once the weight of the patient is known, the physicians only have to open the book at the page corresponding to the weight and all the medications with their calculated dosage are provided. The primary goal of this study is to evaluate the number of dosage error during simulated pediatric resuscitation comparing residents using the handbook vs. utilisation of a chart providing non-calculated dosage. This will be an experimental crossover trial among 40 residents performing four simulated case-scenarios in a high-fidelity simulation lab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 6, 2016
April 1, 2016
6 months
September 27, 2015
April 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Having at least one dosage error in any of the medications during the case for a participant
Difference of \> 10% of the recommended drug dosage for any of the medication provided during the simulated case scenario. To be perfect, there must be no error among all drugs provided.
During the simulation (10 minutes)
Secondary Outcomes (2)
Dosage error in any for all individual medications during the case for a participant
During the simulation (10 minutes)
Time for first drug prescription for each case per participant
During the simulation (10 minutes)
Study Arms (2)
Handbook
EXPERIMENTALResuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.
Medication chart
ACTIVE COMPARATORMedication chart who provides drug dosages for each weight for children. For example,it is written that the dosage of epinephrin is 0.01 mg/kg.
Interventions
Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.
Medication chart who provides drug dosages for each weight for children. For example,it is written that the dosage of epinephrin is 0.01 mg/kg.
Eligibility Criteria
You may qualify if:
- Residents doing a rotation in pediatrics emergency medicine
You may not qualify if:
- Resident who participated in a previous month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Sainte-Justine
Montreal, Quebec, H3T1C5, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc, FRCPC
Study Record Dates
First Submitted
September 27, 2015
First Posted
September 30, 2015
Study Start
September 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 6, 2016
Record last verified: 2016-04