Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study
Overview
- Phase
- Phase 4
- Intervention
- Midazolam
- Conditions
- Dormicum
- Sponsor
- Carmel Medical Center
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- time until sedation is achieved
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Muriel Konopnicki
Head of Pediatric emergency room
Carmel Medical Center
Eligibility Criteria
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.
Arms & Interventions
oral midazolam
oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.
Intervention: Midazolam
intranasal midazolam
intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
Intervention: Midazolam
buccal midazolam
buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
Intervention: Midazolam
Outcomes
Primary Outcomes
time until sedation is achieved
Time Frame: 1 hour
duration of sedation
Time Frame: 4 hour
time from achieving sedation until reaching full consciousness
convenience of administration
Time Frame: 15 minutes
described by the parent and the physician by a numerical rating scale (NRS) questionaire
efficacy of the sedation
Time Frame: 4 hours
described by the parent, nurse and physician by a NRS questionaire