Clinical trial NCT04760041: Nebulized vs. Oral Midazolam Sedation in Pediatric Anesthesia: A Randomized Comparative Study
Official title: Nebulized Midazolam vs. Oral Midazolam as a Sedative Premedication in Pediatric Anesthesia: A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Sedation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Eligibility 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

Primary outcomes:
measure: Time required to reach a satisfactory level of sedation
timeFrame: from time of applying the nebulizer until 30 minutes
Secondary outcomes:
measure: Acceptability of method of administration of midazolam by a grading system
timeFrame: from time of giving midazolam oral or nebulized till 30 minutes
measure: Ease of separation from parents
timeFrame: from 30 minutes after receiving midazolam till transfer to operating room
measure: acceptability of Face mask by grading systen
timeFrame: from time of applying face mask till time of getting asleep at 1 minute intervals
measure: Recovery time
timeFrame: time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals
measure: Changes in mean arterial blood pressure
timeFrame: from start of sedation till 1 hour postoperative at 5 minute intervals
measure: changes in oxygen saturation
timeFrame: from start of sedation till 1 hour postoperative at 5 minute intervals
measure: changes in heart rate
timeFrame: from start of sedation till 1 hour postoperative at 5 minute intervals
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine Cairo university
Study officials:
References: