Clincosm LogoSign in Get a demo

Nebulized vs. Oral Midazolam Sedation in Pediatric Anesthesia: A Randomized Comparative Study

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04760041
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
5.3
Actual Duration (Months)
13.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics.

Condition or Disease Intervention/Treatment Phase
  • Drug: Midazolam nebulized
  • Drug: Midazolam oral solution
 N/A

Detailed Description

This study is to be carried out to compare nebulized midazolam and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatric surgical patients.

In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for undergoing general or uro-surgical operations under general anesthesia will be included in this double-blinded study. Patients will be randomly assigned into two equal groups, each group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA.

level of sedation will be compared between both groups

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Nebulized Midazolam vs. Oral Midazolam as a Sedative Premedication in Pediatric Anesthesia: A Randomized Comparative Study
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Jul 15, 2021
Actual Study Completion Date :
Aug 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: nebulized midazolam group

36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice 30 min before undergoing general anesthesia

Drug: Midazolam nebulized
midazolam nebulized
Other Names:
  • nebulizer

    		•
    Active Comparator: oral midazolam group

    36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing anesthesia

    Drug: Midazolam oral solution
    midazolam given oral
    Other Names:
  • oral

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time required to reach a satisfactory level of sedation [from time of applying the nebulizer until 30 minutes]

      time to reach ramsay sedation score 4

    Secondary Outcome Measures

    1. Acceptability of method of administration of midazolam by a grading system [from time of giving midazolam oral or nebulized till 30 minutes]

      Facemask acceptance will be graded as poor (terrified, crying, and combative),fair (moderate fear of mask not calmed with reassurance),good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily).

    2. Ease of separation from parents [from 30 minutes after receiving midazolam till transfer to operating room]

      using ease of separation and induction scoring system: Excellent: patient unafraid, cooperative, or asleep Good: slight fear and/or crying, quiet with reassurance Fair: moderate fear and crying, not quiet with reassurance Poor: crying, need for restraint

    3. acceptability of Face mask by grading systen [from time of applying face mask till time of getting asleep at 1 minute intervals]

      Facemask acceptance was graded as poor (terrified, crying, and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily)

    4. Recovery time [time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals]

      time to recover

    5. Changes in mean arterial blood pressure [from start of sedation till 1 hour postoperative at 5 minute intervals]

      Changes in mean arterial blood pressure measured in mmHg

    6. changes in oxygen saturation [from start of sedation till 1 hour postoperative at 5 minute intervals]

      changes in oxygen saturation

    7. changes in heart rate [from start of sedation till 1 hour postoperative at 5 minute intervals]

      changes in heart rate changes in heart rate (beats per minute)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients from 2 to 6 years undergoing uro-surgery and general surgical procedures.

    • Duration of surgery 1-2 hours

    • Gender eligible for the study: both.

    • ASA I-II.

    Exclusion Criteria:

    • ASA III-IV

    • Patients with elevated levels of serum ALT, Creatinine.

    • Emergency surgeries.

    • Pre-existing neurologic disease.

    • Parent refusal.

    • History of allergy to midazolam.

    • Patients with atopy or a history of asthma.

    • Lengthy procedures of more than 2 hours

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine Cairo university Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherif Mohamed Abd El Moneim Soaida, MD, Assistant professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04760041
    Other Study ID Numbers:
    • SMS2021-1
    First Posted:
    Feb 18, 2021
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Midazolam

    Study Results

    No Results Posted as of Apr 11, 2022