NCT06018662

Brief Summary

An interventional study that aims to design, establish and implement an electronic application for management of the usage of anesthetics, antimicrobials, and analgesics in a pediatric surgery department, and assess the impact of the implementation of an electronic medication management application on the appropriateness of medication use in a pediatric surgery department

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

August 3, 2023

Last Update Submit

January 30, 2024

Conditions

Medication Management

Keywords

Pediatric surgeryMobile applicationMedication errors

Outcome Measures

Primary Outcomes (1)

  • Appropriateness of medications (anesthetics, antimicrobials, and analgesics) used in different types of surgeries

    Determined through measuring incidence of medication errors and drug related problems

    One year

Secondary Outcomes (3)

  • Cost saving

    One year

  • Cost avoidance

    one year

  • Time saving

    one year

Study Arms (2)

Control

NO INTERVENTION

Routine department therapy

Interventional

EXPERIMENTAL

Anesthetics, antimicrobials and analgesics are selected and age/weight doses are calculated using the medication management mobile application

Other: A medication management mobile application

Interventions

A medication management mobile applicationOTHER

A mobile application to select the most appropriate drugs for anesthetics, antimicrobials and analgesics, in addition to dose calculations

Interventional

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients undergoing any of the following surgeries: Circumcision, Inguinal Hernia, Hypospadias, Esophageal dilatation, uncomplicated Appendectomy, and complicated Appendectomy

You may not qualify if:

  • Cardiac patients
  • Diabetic patients
  • Hypertensive patients
  • Immunocompromised patients
  • Patients with renal and/or liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Nasr City, Egypt

RECRUITING

Study Officials

  • Mai Fawaz, Master's degree

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mai Fawaz, Master's

CONTACT

+20 1221190802May.gamal21@pharma.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Control group (138 patients): The medications selection and dosage will be performed according to the department policy without using the application. Intervention group (138 patients): The physicians use the application for appropriate medications selection and dosage calculation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 30, 2023

Study Start

November 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)