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

Sponsor

St. Justine's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02563912

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Handbook Other: Medication chart	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Having at least one dosage error in any of the medications during the case for a participant [During the simulation (10 minutes)]
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.

Secondary Outcome Measures

Dosage error in any for all individual medications during the case for a participant [During the simulation (10 minutes)]
Difference of > 10% of the recommended drug dosage for any of the medication provided during the simulated case scenario
Time for first drug prescription for each case per participant [During the simulation (10 minutes)]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Residents doing a rotation in pediatrics emergency medicine

Exclusion Criteria:

Resident who participated in a previous month

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Sainte-Justine	Montreal	Quebec	Canada	H3T1C5

Sponsors and Collaborators

St. Justine's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jocelyn Gravel, MD, MSc, FRCPC, St. Justine's Hospital

ClinicalTrials.gov Identifier:

NCT02563912

Other Study ID Numbers:

Resuscitaion book

First Posted:

Sep 30, 2015

Last Update Posted:

Apr 6, 2016

Last Verified:

Apr 1, 2016

Keywords provided by Jocelyn Gravel, MD, MSc, FRCPC, St. Justine's Hospital

Study Results

No Results Posted as of Apr 6, 2016