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

NCT ID: NCT05872087

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-02-01

Brief Summary

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

Detailed Description

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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

Conditions

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Emergence Delirium Anxiety Preoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Dexmedetomidine

will receive nebulized Dexmedetomidine 3 µg/kg

Group Type ACTIVE_COMPARATOR

Nebulised Dexmeditomidine

Intervention Type DRUG

premedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries

Midazolam

will receive nebulized Midazolam 0.3 mg/kg

Group Type ACTIVE_COMPARATOR

Nebulised Midazolam

Intervention Type DRUG

premedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries

Interventions

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Nebulised Dexmeditomidine

premedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries

Intervention Type DRUG

Nebulised Midazolam

premedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries

Intervention Type DRUG

Other Intervention Names

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premedication by nebulised dexmeditomidine Premedication by nebulised midazolam

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ainshams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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midazolam vs dexmedetomidine

Identifier Type: -

Identifier Source: org_study_id

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