- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06389318
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Banha, Egypt, 13511
- Benha University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ramsay sedation score
Time Frame: RSSs were recorded just immediately before and at 10 , 20 , 30 min after dosing
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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.
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RSSs were recorded just immediately before and at 10 , 20 , 30 min after dosing
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental separation anxiety scale
Time Frame: Preoperatively
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Anxiety score 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; and (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
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Preoperatively
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Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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