Faculty of medicine Cairo university
Cairo, Egypt
NCT Number: NCT04760041
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.
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Notify Me2 year–6 year
All sexes
Interventional
Not applicable
Cairo, Egypt
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
midazolam nebulized
Other names: nebulizer
midazolam given oral
Other names: oral
Time frame: from time of applying the nebulizer until 30 minutes
time to reach ramsay sedation score 4
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).
Time frame: from 30 minutes after receiving midazolam till transfer to operating room
using ease of separation and induction scoring system:
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)
Time frame: time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals
time to recover
Time frame: from start of sedation till 1 hour postoperative at 5 minute intervals
Changes in mean arterial blood pressure measured in mmHg
Time frame: from start of sedation till 1 hour postoperative at 5 minute intervals
changes in oxygen saturation
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)
Cairo University
Other
Nebulized Midazolam vs. Oral Midazolam as a Sedative Premedication in Pediatric Anesthesia: A Randomized Comparative Study
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