Efficacy of iv Fentanyl Citrate Administered Oral as a Pediatric Premedication

Efficacy of the Intravenous Formulation of Fentanyl Citrate Administered Orally as Premedication in Paediatric Patients Undergoing Open Cardiac Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: Oral premedication

Detailed Description

In this double-blinded randomized controlled study, after approval by the local ethics committee, paediatric patients, aged 1 to 7 years, scheduled for elective surgical procedures for correction of congenital heart disease will be enrolled. 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. After assessing the patient for anaesthesia, informed consent of patients about study and anaesthesia will be obtained.Children will be kept off solid food for 6 hours and of clear fluids for 2 hours. The premedication will be administered orally mixed with equal volume of 5% dextrose and using a 5-ml syringe, 30 minutes before admission to operating room by a member of the nursing staff unaware of the group allocation, in the preoperative holding area, in the presence of one parent. A randomized block design will be used for allocation of patients into two groups (50 patients each); one group of patients will receive midazolam (Group M) and the other will receive fentanyl (Group F) as a sedative premedication.

1. Group M: patients will be premedicated with the undiluted IV formulation of Midazolam (5 mg/mL), 0.5 mg/kg up to 15 mg per patient. The dose is chosen to be similar to the dose of midazolam used in other previous studies ().
2. Group F: patients will be premedicated with the undiluted IV formulation of fentanyl citrate (50 µg/mL), 10 µg/kg up to 400 µg per patient. The dose is chosen to be similar to the dose of OTFC used in other previous studies

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ibrahim Mabrouk, Phd; Phone Number: 00201224336786; Email: ibrahim_wama@hotmail.com
• Study Contact Backup: Name: Islam Elbardan, Phd; Phone Number: +20 111 227 8083; Email: Islamelbardan@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt, 23541
    • Recruiting
    • Alexandria University
    • Contact: Nagwa Kobea, Phd; Phone Number: +20 122 336 8233; Email: kobea@yahoo.com
  • Alexandria, Egypt, 24356
    • Recruiting
    • Alexandria University
    • Contact: Nagwa Kobea, Phd; Phone Number: +20 122 336 8233; Email: kobea@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group M; patients will be premedicated with the undiluted IV formulation of Midazolam	Drug: Oral premedication; Oral anesthesia premedication for congenital Cardiac surgery; Other Names: Midazolam , fentanyl
Active Comparator: Group F; patients will be premedicated with the undiluted IV formulation of fentanyl citrate	Drug: Oral premedication; Oral anesthesia premedication for congenital Cardiac surgery; Other Names: Midazolam , fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: = Spits/vomits the premedication.; = Accepts it/but dislikes the taste.; = 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: = Inconsolable cry.; = Complaining.; = Quiet but awake.; = 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.; =Anxious and agitated or restless, or both.; =Cooperative, oriented, and calm.; =Responsive to commands only.; =Exhibiting brisk response to light glabellar tap or loud auditory stimulus.; =Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus.; =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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic effects	Heart rate (beats/min)	1 year
Adverse effects	nausea, vomiting, illusion, pruritis, paradoxical hyperactive reactions	1 year

Collaborators and Investigators

• Sponsor: University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): June 25, 2022
• Study Completion (Anticipated): July 25, 2022

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam
• Other Study ID Numbers: 124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No