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

Phase 1

Completed

• Conditions: Anxiety Preoperative; Emergence Delirium
• Interventions: Drug: Nebulised Midazolam; Drug: Nebulised Dexmeditomidine

• Registration Number: NCT05872087
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-03-22
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-24
• Primary Completion: 2023-09-01
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	Nebulised Midazolam	will receive nebulized Midazolam 0.3 mg/kg
Dexmedetomidine	Nebulised Dexmeditomidine	will receive nebulized Dexmedetomidine 3 µg/kg

Primary Outcome Measures

Name	Time	Method
level of preoperative anxiety	30 minutes after drug administration	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
Incidence of emergence delirium	immediate postoperative	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt