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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04760041
Recruitment Status : Completed
First Posted : February 18, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Sherif Mohamed Abd El Moneim Soaida, MD, Cairo University

Study Description
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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
Preoperative Sedation Drug: Midazolam nebulized Drug: Midazolam oral solution Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2021
Actual Primary Completion Date : July 15, 2021
Actual Study Completion Date : August 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: oral


Outcome Measures
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Primary Outcome Measures :
  1. Time required to reach a satisfactory level of sedation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: from 30 minutes after receiving midazolam till transfer to operating room ]

    using ease of separation and induction scoring system:

    1. Excellent: patient unafraid, cooperative, or asleep
    2. Good: slight fear and/or crying, quiet with reassurance
    3. Fair: moderate fear and crying, not quiet with reassurance
    4. Poor: crying, need for restraint

  3. acceptability of Face mask by grading systen [ Time Frame: 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 Frame: time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals ]
    time to recover

  5. Changes in mean arterial blood pressure [ Time Frame: 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 [ Time Frame: from start of sedation till 1 hour postoperative at 5 minute intervals ]
    changes in oxygen saturation

  7. changes in heart rate [ Time Frame: 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
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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760041


Locations
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Egypt
Faculty of medicine Cairo university
Cait, Egypt
Sponsors and Collaborators
Cairo University
More Information
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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: February 18, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action