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

Study Overview
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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

Official Title
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Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Reducing Preoperative Anxiety and Emergence Delirium in Children Undergoing Lower Abdominal Surgeries

Conditions
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Emergence Delirium, Anxiety Preoperative

Intervention / Treatment
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* Drug: Nebulised Dexmeditomidine
* Drug: Nebulised Midazolam


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>will receive nebulized Dexmedetomidine 3 µg/kg | Drug: Nebulised Dexmeditomidine<br>* premedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries<br>* Other names: premedication by nebulised dexmeditomidine;|
| Active Comparator: Midazolam<br>will receive nebulized Midazolam 0.3 mg/kg | Drug: Nebulised Midazolam<br>* premedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries<br>* Other names: Premedication by nebulised midazolam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of preoperative anxiety | The level of anxiety of the child during separation from parents according to Parental separation anxiety scale (PSAS), with a 4-point scale as: 1=easy separation; 2=whimpers, but is easily reassured, not clinging; 3=cries and cannot be easily reassured, but not clinging to parents and 4=crying and clinging to parents | 30 minutes after drug administration | 
| Incidence of emergence delirium | Incidence of emergence delirium, wake up behaviour will be assessed according to Watcha scale where Score is observed values as follows: 0= asleep, 1=calm, 2=crying but can be consoled, 3=crying but cannot be consoled, 4=agitating and thrashing around | immediate postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the level of sedation | The level of sedation when the child first seen in the operating room 30 minutes after sedation using Ramsey sedation scale | 30 minutes after drug administration | 
| hemodynamic changes | number of participants experienced any hemodynamic changes if more than 20% change in mean arterial pressure (MAP) and Heart Rate (HR). | perioperative | 
| PONV | Incidence of post-operative nausea and vomiting. | perioperative | 
| recovery time | Recovery time, time between laryngeal mask removal and discharge from recovery room. | up to 2 hours postoperative | 
| total fentanyl use | Total fentanyl use during operation | intraoperative |