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

Carmel Medical Center90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Dormicum Conscious Sedation Children

Interventions

Eligibility

Sex: ALLMin age: 5 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

time until sedation is achieved

Time frame: 1 hour

duration of sedation

time from achieving sedation until reaching full consciousness

Time frame: 4 hour

convenience of administration

described by the parent and the physician by a numerical rating scale (NRS) questionaire

Time frame: 15 minutes

efficacy of the sedation

described by the parent, nurse and physician by a NRS questionaire

Time frame: 4 hours