Pre-calculated Doses of Medication for Pediatric Resuscitation, a Simulation Experimental Trial

Pre-calculated Doses of Medication for Pediatric Resuscitation, a Simulation Cross-over Randomized Experimental Trial

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Handbook; Other: Medication chart

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Residents doing a rotation in pediatrics emergency medicine

Exclusion Criteria:

• Resident who participated in a previous month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Handbook; 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.	Other: Handbook; 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.
Active Comparator: Medication chart; 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.	Other: Medication chart; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage error in any for all individual 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	During the simulation (10 minutes)
Time for first drug prescription for each case per participant	Time required for the prescription of the first dose of medication. From beginning of the case until the first dose of epinephrine is completely prescribed (Dosage included)	During the simulation (10 minutes)

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 27, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Children; simulation; resuscitation; medication error
• Other Study ID Numbers: Resuscitaion book