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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06389318
Other study ID # RC 29-11-2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 26, 2023
Est. completion date April 24, 2024

Study information

Verified date April 2024
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients


Description:

Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients. The administration of sedatives to a child before entering a surgical room is the most common way of reducing the child's distress and allows the child to undergo smooth anesthesia induction. Chloral hydrate is a widely used sedative for young children undergoing imaging studies, with a high success rate. Dexmedetomidine is a highly selective alpha-2 agonist for paediatric sedation. It produces sedation like natural non-rapid eye movement sleep and has respiratory-sparing effect.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 24, 2024
Est. primary completion date March 26, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years to 7 Years
Eligibility Inclusion Criteria: - aged 2 to 7 - American Society of Anaesthesiology (ASA) ? and ? scheduled for inguinal hernia repair Exclusion Criteria: - sensitivity to dexmedetomidine or midazolam, - infection of the upper respiratory tract, - severe liver or kidney disease, organ dysfunction, - cardiac arrhythmia or congenital heart disease

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
buccal midazolam +oral placebo syrup
Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, prepared at abo Elreesh pharmacy, Elmoneerah , Egypt) at 50 mg /kg, intranasal dexmedetomidine at 2 µg/kg and buccal normal saline. Dexmedetomidine used was preservative-free dexmedetomidine (Precedex, 2ml ampoule,100 ug /ml, Hospira, Inc, Rocky Mount, USA) in a concentration of 100 µg/mL. Undiluted drug was withdrawn into a 1 mL tuberculin syringe.
oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline
Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, prepared at abo Elreesh pharmacy, Elmoneerah , Egypt) at 50 mg /kg, intranasal dexmedetomidine at 2 µg/kg and buccal normal saline. Dexmedetomidine used was preservative-free dexmedetomidine (Precedex, 2ml ampoule,100 ug /ml, Hospira, Inc, Rocky Mount, USA) in a concentration of 100 µg/mL. Undiluted drug was withdrawn into a 1 mL tuberculin syringe.

Locations

Country Name City State
Egypt Benha University Banha

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ramsay sedation score The scoring criteria were as follows: (1) patient shows anxiety and restlessness; (2) patient is cooperative, oriented, and quiet; (3) patient is responsive to instructions; (4) patient shows somnolence and responsive to the tapping of the glabella or to loud auditory stimuli; (5) patient shows somnolence and unresponsive to the tapping of the glabella or to loud auditory stimuli; and (6) patient shows somnolence without any response. RSSs were recorded just immediately before and at 10 minutes , 20 minutes , 30 minutes after dosing
Secondary Parental separation anxiety scale Parental separation anxiety scale was determined when the child was separated from the parents according to four levels:
easy to separate
sobbing but easy to cease
crying loudly and difficult to stop but without holding the parents and not letting them go
crying loudly and holding the parents and not willing to let them go. PSAS scores of 1 and 2 were considered "successful separation from parents
Preoperatively
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