Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair

Inguinal Hernia Repair Clinical Trial

Official title:

Comparison Between Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Reducing Parental Separation Anxiety in Children Undergoing Inguinal Hernia Repair: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06389318
• Other study ID #: RC 29-11-2023
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Repair

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