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OpenTrials
Completed

NCT Number: NCT02958605

Smartphone Apps for Pediatric Resuscitation

Medication errors are common in children. Characteristics of errors during critical situations in the Emergency Department are ill-defined and might be more frequent than previously thought. However, optimal strategies to eliminate the risk of prescribing errors remain unknown.

Many smartphone apps have been suggested over the last years with some of them designed to calculate medication dosage for children. The impact of these apps to decrease dosage error has never been evaluated in resuscitation setting.

The aim of the study is to evaluate whether the use of a smartphone application designed to calculate medication doses decreases prescribing errors among residents during pediatric simulated resuscitations.

This will be a crossover-randomized trial using high fidelity simulation among 40 residents rotating in the pediatric emergency department.

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Key information

Conditions

Status Epilepticus Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residents (PGY1 to PGY4)
  • Completing a rotation in pediatric emergency

Exclusion criteria

  • Residents who previously participated in this study

Treatment and study plan

Smartphone Apps

Device

If already own a smartphone application dedicated to calculate medication dosage for children, the participant will be allowed to use his/her own application. Otherwise, the resident will be offered to chose among a list of applications paid by the research team (PediSafe, PediStat, Palm Pedi, Safedose, EZdrip peds). He/she will be instructed to practice with a few time at home before doing the simulations.

Handbook

Device

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.

Primary outcomes

  1. Medication error

    Time frame: During resuscitation

    The primary outcome is the presence of a medication error. An error will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.

Secondary outcomes

  1. Proportion of tenfold error

    Time frame: During resuscitation

    A tenfold error will be defined as a drug dose varying by a factor of 10 compared to the recommended dose.

  2. Time for prescribing the first medication

    Time frame: During the simulation (10 minutes)

    Time from the beginning of the simulation and complete prescription (oral or written) of the first medication.

  3. Error in bolus medication

    Time frame: during simulation

    An error in bolus medication will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.

  4. Error in perfusion medication

    Time frame: during simulation

    An error in perfusion medication will be defined as a drug dose varying by more than 20% from the recommended dose. This can be related to a preparation error or a flow error.

  5. User satisfaction

    Time frame: 2 weeks

    Satisfaction of the resident with both tools using a Visual analog scale

  6. User confidence

    Time frame: 2 weeks

    Confidence of the resident while using both tools using a Visual analog scale

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • Canadian Medical Protective Association

Registry information

Official study title

Smartphone Medical Applications to Reduce Treatment Dosage Errors in Pediatric Resuscitation; a Randomized Simulation Trial

Acronym: SMARTER

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2016
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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