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NCT Number: NCT05872087

Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam 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

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Key information

Conditions

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

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ainshams University

Cairo, 0000, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebulised Dexmeditomidine

Drug

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

Other names: premedication by nebulised dexmeditomidine

Nebulised Midazolam

Drug

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

Other names: Premedication by nebulised midazolam

Primary outcomes

  1. level of preoperative anxiety

    Time frame: 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

  2. Incidence of emergence delirium

    Time frame: 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 outcomes

  1. the level of sedation

    Time frame: 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

  2. hemodynamic changes

    Time frame: perioperative

    number of participants experienced any hemodynamic changes if more than 20% change in mean arterial pressure (MAP) and Heart Rate (HR).

  3. PONV

    Time frame: perioperative

    Incidence of post-operative nausea and vomiting.

  4. recovery time

    Time frame: up to 2 hours postoperative

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

  5. total fentanyl use

    Time frame: intraoperative

    Total fentanyl use during operation

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 24, 2023
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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