Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children

Study Overview
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Brief Summary
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Currently Midazolam sedation is the standard of care for minor invasive procedures in pediatric patients; its use is restricted to two routes of administration for this purpose oral and intranasal. A third route of administration (buccal) is tested and approved for seizure management. In the investigators' study the researchers investigate the buccal route of administration versus oral or intranasal administration for sedation. The investigators' hypothesis is that buccal route of administration is more convenient than intranasal and better absorbed than oral.

Official Title
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Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study

Conditions
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Dormicum, Conscious Sedation, Children

Intervention / Treatment
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* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 5 months to 6 years. need to undergo a minimal invasive procedure that requires light sedation. ASA (American Society of Anesthesiologists) I-II parent that can read, understand and sign an informed consent form Exclusion Criteria: patients with life threatening conditions. patients with respiratory or cardiac chronic illnesses or ASA other than I-II. patients with traumatic injury for the nose or the oral cavity. patients that would not or cannot take the drug in the route picked in a randomized way.

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral midazolam<br>oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure. | Drug: Midazolam<br>* comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.<br>* Other names: Dormicum;|
| Active Comparator: intranasal midazolam<br>intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure | Drug: Midazolam<br>* comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.<br>* Other names: Dormicum;|
| Active Comparator: buccal midazolam<br>buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure | Drug: Midazolam<br>* comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.<br>* Other names: Dormicum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time until sedation is achieved |  | 1 hour | 
| duration of sedation | time from achieving sedation until reaching full consciousness | 4 hour | 
| convenience of administration | described by the parent and the physician by a numerical rating scale (NRS) questionaire | 15 minutes | 
| efficacy of the sedation | described by the parent, nurse and physician by a NRS questionaire | 4 hours |