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

NCT05872087 | Completed Phase 1 DMC

• 1 other identifier: midazolam vs dexmedetomidine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Emergence Delirium; Anxiety Preoperative

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• the level of sedation

  30 minutes after drug administration

• hemodynamic changes

  perioperative

• PONV

  perioperative

• recovery time

  up to 2 hours postoperative

• total fentanyl use

  intraoperative

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

will receive nebulized Dexmedetomidine 3 µg/kg

Drug: Nebulised Dexmeditomidine

Midazolam

ACTIVE COMPARATOR

will receive nebulized Midazolam 0.3 mg/kg

Drug: Nebulised Midazolam

Interventions

Nebulised Dexmeditomidine DRUG

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

Also known as: premedication by nebulised dexmeditomidine

Dexmedetomidine

Nebulised Midazolam DRUG

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

Also known as: Premedication by nebulised midazolam

Midazolam

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-8 years
• ASA I\&II
• Undergoing lower abdominal surgeries for example hernia repair and circumcision

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, 0000, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 24, 2023
• Study Start: November 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)