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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05872087
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Nebulised Dexmeditomidine
  • Drug: Nebulised Midazolam
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Reducing Preoperative Anxiety and Emergence Delirium in Children Undergoing Lower Abdominal Surgeries
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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

    2. hemodynamic changes [perioperative]

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

    3. PONV [perioperative]

      Incidence of post-operative nausea and vomiting.

    4. recovery time [up to 2 hours postoperative]

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

    5. total fentanyl use [intraoperative]

      Total fentanyl use during operation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ainshams University Cairo Egypt 0000

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05872087
    Other Study ID Numbers:
    • midazolam vs dexmedetomidine
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Delirium
    Emergence Delirium
    Midazolam

    Study Results

    No Results Posted as of May 24, 2023