Clinical trial NCT04991298: Efficacy of iv Fentanyl Citrate Administered Oral as a Pediatric Premedication
Official title: Efficacy of the Intravenous Formulation of Fentanyl Citrate Administered Orally as Premedication in Paediatric Patients Undergoing Open Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Patient's acceptance of the medication (score from 1 to 3)
timeFrame: 1 year
measure: Reaction to separation from parents (score from 1 to 4)
timeFrame: 1 year
measure: Sedation score ( score from 1 to 6)
timeFrame: 1 year
measure: Ease of Induction of general anaesthesia (score from 1 to 4)
timeFrame: 1 year
Secondary outcomes:
measure: Hemodynamic effects
timeFrame: 1 year
measure: Adverse effects
timeFrame: 1 year
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References: