Efficacy of iv Fentanyl Citrate Administered Oral as a Pediatric Premedication

Not Applicable

• Conditions: Anesthesia, Local
• Interventions: Drug: Oral premedication

• Registration Number: NCT04991298
• Lead Sponsor: University of Alexandria

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

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 Timeline

• Study First Submitted: 2021-05-27
• Study Start: 2021-06-01
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-02
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05
• Primary Completion: 2022-06-25
• Study Completion: 2022-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group F	Oral premedication	patients will be premedicated with the undiluted IV formulation of fentanyl citrate
Group M	Oral premedication	patients will be premedicated with the undiluted IV formulation of Midazolam

Primary Outcome Measures

Name	Time	Method
Ease of Induction of general anaesthesia (score from 1 to 4)	1 year	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
Reaction to separation from parents (score from 1 to 4)	1 year	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.
Patient's acceptance of the medication (score from 1 to 3)	1 year	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.
Sedation score ( score from 1 to 6)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	1 year	nausea, vomiting, illusion, pruritis, paradoxical hyperactive reactions
Hemodynamic effects	1 year	Heart rate (beats/min)

Trial Locations

Locations (1)

Alexandria university; 🇪🇬 Alexandria, Egypt