Efficacy of iv Fentanyl Citrate Administered Oral as a Pediatric Premedication

NCT04991298 | Unknown

• 1 other identifier: 124
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

evaluate the efficacy of the intravenous formulation of fentanyl citrate administered orally as a sedative premedication, we will compare it with oral midazolam, as a gold standard premedication, in paediatric congenital cardiac surgeries

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (4)

• Patient's acceptance of the medication (score from 1 to 3)

  Response of the child to acceptance of premedication will be assessed on a three-point scale: 1. = Spits/vomits the premedication. 2. = Accepts it/but dislikes the taste. 3. = Accepts it/likes the taste.

  1 year

• Reaction to separation from parents (score from 1 to 4)

  The response of the children when taken away from the parents will be recorded as the end point of premedication. It will be assessed on a four point scale: 1. = Inconsolable cry. 2. = Complaining. 3. = Quiet but awake. 4. = Sleepy.

  1 year

• Sedation score ( score from 1 to 6)

  The degree of sedation, when the child will be first seen in the operating room (OR), will be scaled from 1 to 6 according to the Ramsay Sedation Scale. 1. =Anxious and agitated or restless, or both. 2. =Cooperative, oriented, and calm. 3. =Responsive to commands only. 4. =Exhibiting brisk response to light glabellar tap or loud auditory stimulus. 5. =Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus. 6. =Unresponsive.

  1 year

• Ease of Induction of general anaesthesia (score from 1 to 4)

  A 4-point scoring system will used to evaluate the child's behaviour at anaesthesia induction and mask acceptance 1= Calm and cooperating 2 =Anxious but without resistance 3 =Anxious with slight resistance 4 =Crying and/or struggling against mask

  1 year

Secondary Outcomes (2)

• Hemodynamic effects

  1 year

• Adverse effects

  1 year

Study Arms (2)

Group M

ACTIVE COMPARATOR

patients will be premedicated with the undiluted IV formulation of Midazolam

Drug: Oral premedication

Group F

ACTIVE COMPARATOR

patients will be premedicated with the undiluted IV formulation of fentanyl citrate

Drug: Oral premedication

Interventions

Oral premedication DRUG

Oral anesthesia premedication for congenital Cardiac surgery

Also known as: Midazolam , fentanyl

Group F; Group M

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• paediatric congenital heart disease patients, aged 1 to 7 years, scheduled for elective surgical procedures for correction of congenital heart disease

You may not qualify if:

• Patients with hepatic or renal disorders, gastrointestinal tract disorders or malformation, conduction disorders, coronary artery disease, emergency operations, mental disabilities, and known reactions to the drugs to be used will be excluded.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (2)

Alexandria university

Alexandria, 23541, Egypt

RECRUITING

Alexandria university

Alexandria, 24356, Egypt

RECRUITING

MeSH Terms

Interventions

Premedication; Midazolam; Fentanyl

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Ibrahim Mabrouk, Phd

CONTACT

00201224336786; ibrahim_wama@hotmail.com

Islam Elbardan, Phd

CONTACT

+20 111 227 8083; Islamelbardan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: August 5, 2021
• Study Start: June 1, 2021
• Primary Completion: June 25, 2022
• Study Completion: July 25, 2022
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)