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

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

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

Study Overview

• Status: Completed
• Conditions: Emergence Delirium; Anxiety Preoperative
• Intervention / Treatment: Drug: Nebulised Dexmeditomidine; Drug: Nebulised Midazolam

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 0000
    • AinShams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: midazolam vs dexmedetomidine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No