Efficacy of iv Fentanyl Citrate Administered Oral as a Pediatric Premedication

Study Overview
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Brief Summary
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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
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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. 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 (). 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

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

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: Oral premedication


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |