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
Overview
- Phase
- Not Applicable
- Intervention
- buccal midazolam +oral placebo syrup
- Conditions
- Inguinal Hernia Repair
- Sponsor
- Benha University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Ramsay sedation score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Ramy Mousa
Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
Benha University
Eligibility Criteria
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
Arms & Interventions
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
Intervention: buccal midazolam +oral placebo syrup
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.
Intervention: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline
Outcomes
Primary Outcomes
Ramsay sedation score
Time Frame: 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 Outcomes
- Parental separation anxiety scale(Preoperatively)