Inguinal Hernia Repair
Conditions
Keywords
Midazolam, Dexmedetomidine, Chloral Hydrate
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.
Interventions
DRUGbuccal 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 Undiluted drug was withdrawn into a 1 mL tuberculin syringe.
DRUGoral 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 Undiluted drug was withdrawn into a 1 mL tuberculin syringe.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Both participant and the care-provider in this trial were blinded.
Intervention model description
Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed