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

Emergence Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872087
• Other study ID #: midazolam vs dexmedetomidine
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Preoperative
• Delirium
• Emergence Delirium

Intervention

Drug:
• Nebulised Dexmeditomidine
premedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries
• Nebulised Midazolam
premedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries

Locations

Country	Name	City	State
Egypt	Ainshams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	hemodynamic changes	number of participants experienced any hemodynamic changes if more than 20% change in mean arterial pressure (MAP) and Heart Rate (HR).	perioperative
Secondary	PONV	Incidence of post-operative nausea and vomiting.	perioperative
Secondary	recovery time	Recovery time, time between laryngeal mask removal and discharge from recovery room.	up to 2 hours postoperative
Secondary	total fentanyl use	Total fentanyl use during operation	intraoperative