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

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

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

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia Repair
• Intervention / Treatment: Drug: buccal midazolam +oral placebo syrup; Drug: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banha, Egypt, 13511
    • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: buccal midazolam group; 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; 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.; Other Names: Group A
Experimental: oral chloral hydrate and intranasal dexmedetomidine group; 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; 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.; Other Names: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Ramy Saleh, MD, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2023
• Primary Completion (Actual): March 26, 2024
• Study Completion (Actual): April 24, 2024

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Midazolam; Chloral Hydrate
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine; Chloral Hydrate
• Other Study ID Numbers: RC 29-11-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be available upon reasonable request from the principle investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No