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

Benha University

Status: Completed

Conditions: Inguinal Hernia Repair

Treatments: Drug: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline; Drug: buccal midazolam +oral placebo syrup

Study type: Interventional

Funder types: Other

Identifiers

NCT06389318

RC 29-11-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 2 to 7
• American Society of Anaesthesiology (ASA) І and П 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

buccal midazolam group

Experimental group

Description:

Children received oral placebo syrup, intranasal 0.9 % normal saline at 0.03 ml/kg and buccal midazolam at 0.1 mg/ kg mixed with simple syrup

Treatment:

Drug: buccal midazolam +oral placebo syrup

oral chloral hydrate and intranasal dexmedetomidine group

Experimental group

Description:

Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline.

Treatment:

Drug: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline