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

Preoperative Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04760041
• Other study ID #: SMS2021-1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 10, 2021

Study information

• Verified date: April 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 10, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Preoperative Sedation

Intervention

Drug:
• Midazolam nebulized
midazolam nebulized
• Midazolam oral solution
midazolam given oral

Locations

Country	Name	City	State
Egypt	Faculty of medicine Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Recovery time	time to recover	time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals
Secondary	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
Secondary	changes in oxygen saturation	changes in oxygen saturation	from start of sedation till 1 hour postoperative at 5 minute intervals
Secondary	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