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

Phase 1CompletedNCT05872087

Ain Shams University60 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Emergence Delirium Anxiety Preoperative

Interventions

Nebulised DexmeditomidineDRUG

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

Nebulised MidazolamDRUG

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ainshams University

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: immediate postoperative

Secondary Outcomes

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

Time frame: 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).

Time frame: perioperative

PONV

Incidence of post-operative nausea and vomiting.

Time frame: perioperative

recovery time

Recovery time, time between laryngeal mask removal and discharge from recovery room.

Time frame: up to 2 hours postoperative

total fentanyl use

Total fentanyl use during operation

Data from ClinicalTrials.gov

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