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

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ClinicalTrials.gov Identifier: NCT02563912
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Having at least one dosage error in any of the medications during the case for a participant [ Time Frame: 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 :
  1. Dosage error in any for all individual medications during the case for a participant [ Time Frame: During the simulation (10 minutes) ]
    Difference of > 10% of the recommended drug dosage for any of the medication provided during the simulated case scenario

  2. Time for first drug prescription for each case per participant [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Residents doing a rotation in pediatrics emergency medicine

Exclusion Criteria:

  • Resident who participated in a previous month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563912


Locations
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Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
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Responsible Party: Jocelyn Gravel, MD, MSc, FRCPC, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02563912    
Other Study ID Numbers: Resuscitaion book
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by Jocelyn Gravel, St. Justine's Hospital:
Children
resuscitation
simulation
medication error