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

Not Applicable

Completed

• Conditions: Inguinal Hernia Repair
• Interventions: Drug: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline; Drug: buccal midazolam +oral placebo syrup

• Registration Number: NCT06389318
• Lead Sponsor: Benha University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2023-03-26
• Primary Completion: 2024-03-26
• Status Verified: 2024-04
• Study Completion: 2024-04-24
• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-29
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral chloral hydrate and intranasal dexmedetomidine group	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, at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline.
buccal midazolam group	buccal midazolam +oral placebo syrup	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

Primary Outcome Measures

Name	Time	Method
Ramsay sedation score	RSSs were recorded just immediately before and at 10 minutes , 20 minutes , 30 minutes after dosing	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.

Secondary Outcome Measures

Name	Time	Method
Parental separation anxiety scale	Preoperatively	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

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banha, Egypt