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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563912
• Other study ID #: Resuscitaion book
• Status: Completed
• Phase: N/A
• First received: September 27, 2015
• Last updated: April 5, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Residents doing a rotation in pediatrics emergency medicine

Exclusion Criteria:

• Resident who participated in a previous month

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes