Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Anxiety Preoperative; Emergence Delirium

Treatments: Drug: Nebulised Dexmeditomidine; Drug: Nebulised Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05872087

midazolam vs dexmedetomidine

Details and patient eligibility

About

Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries

Full description

Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries

Enrollment: 60 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children aged 3-8 years
• ASA I&II
• Undergoing lower abdominal surgeries for example hernia repair and circumcision

Exclusion criteria

• Children with chest infection, respiratory disease, cardiac disease
• Children with mental or physical disabilities, treatment with sedatives and anticonvulsants
• Parental refusal
• Allergy to study drugs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Dexmedetomidine

Active Comparator group

Description:

will receive nebulized Dexmedetomidine 3 µg/kg

Treatment:

Drug: Nebulised Dexmeditomidine

Midazolam

Active Comparator group

Description:

will receive nebulized Midazolam 0.3 mg/kg

Treatment:

Drug: Nebulised Midazolam