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

Study Overview
=================
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

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

Conditions
-----------------
Preoperative Sedation

Intervention / Treatment
-----------------
* Drug: Midazolam nebulized
* Drug: Midazolam oral solution


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nebulized midazolam group<br>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<br>* midazolam nebulized<br>* Other names: nebulizer;|
| Active Comparator: oral midazolam group<br>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<br>* midazolam given oral<br>* 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 |