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

Benha University80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Inguinal Hernia Repair

Interventions

buccal midazolam +oral placebo syrupDRUG

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 Undiluted drug was withdrawn into a 1 mL tuberculin syringe.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 salineDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

Benha University

Banhā, Egypt

Outcomes

Primary Outcomes

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.

Time frame: RSSs were recorded just immediately before and at 10 minutes , 20 minutes , 30 minutes after dosing

Secondary Outcomes

Parental separation anxiety scale

Parental separation anxiety scale was determined when the child was separated from the parents according to four levels: 1. easy to separate 2. sobbing but easy to cease 3. crying loudly and difficult to stop but without holding the parents and not letting them go 4. 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

Time frame: Preoperatively

Data from ClinicalTrials.gov

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