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

NCT06389318 | Completed

• 1 other identifier: RC 29-11-2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Inguinal Hernia Repair

Keywords

Midazolam; Dexmedetomidine; Chloral Hydrate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parental separation anxiety scale

  Preoperatively

Study Arms (2)

buccal midazolam group

EXPERIMENTAL

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

Drug: buccal midazolam +oral placebo syrup

oral chloral hydrate and intranasal dexmedetomidine group

EXPERIMENTAL

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.

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

Interventions

buccal midazolam +oral placebo syrup DRUG

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 Undiluted drug was withdrawn into a 1 mL tuberculin syringe.

Also known as: Group A

buccal midazolam group

oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline DRUG

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.

Also known as: Group B

oral chloral hydrate and intranasal dexmedetomidine group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged 2 to 7
• American Society of Anaesthesiology (ASA) І and П scheduled for inguinal hernia repair

You may not qualify if:

• sensitivity to dexmedetomidine or midazolam,
• infection of the upper respiratory tract,
• severe liver or kidney disease, organ dysfunction,
• cardiac arrhythmia or congenital heart disease

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, 13511, Egypt

Location

MeSH Terms

Interventions

Chloral Hydrate

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Ramy Saleh, MD

  Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both participant and the care-provider in this trial were blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

Model Details: Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture)

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: March 26, 2023
• Primary Completion: March 26, 2024
• Study Completion: April 24, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)