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

Nebulized Midazolam vs. Oral Midazolam as a Sedative Premedication in Pediatric Anesthesia: A Randomized Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Preoperative Sedation
• Intervention / Treatment: Drug: Midazolam nebulized; Drug: Midazolam oral solution

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of medicine Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required to reach a satisfactory level of sedation	time to reach ramsay sedation score 4	from time of applying the nebulizer until 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of method of administration of midazolam by a grading system	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).	from time of giving midazolam oral or nebulized till 30 minutes
Ease of separation from parents	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	from 30 minutes after receiving midazolam till transfer to operating room
acceptability of Face mask by grading systen	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)	from time of applying face mask till time of getting asleep at 1 minute intervals
Recovery time	time to recover	time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals
Changes in mean arterial blood pressure	Changes in mean arterial blood pressure measured in mmHg	from start of sedation till 1 hour postoperative at 5 minute intervals
changes in oxygen saturation	changes in oxygen saturation	from start of sedation till 1 hour postoperative at 5 minute intervals
changes in heart rate	changes in heart rate changes in heart rate (beats per minute)	from start of sedation till 1 hour postoperative at 5 minute intervals

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: SMS2021-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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