Inguinal Hernia Repair Clinical Trial
Official title:
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
Verified date | April 2024 |
Source | Benha University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 80 |
Est. completion date | April 24, 2024 |
Est. primary completion date | March 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 7 Years |
Eligibility | Inclusion Criteria: - aged 2 to 7 - American Society of Anaesthesiology (ASA) ? and ? 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Benha University | Banha |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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