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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02408302

Enrollment

Registered

2015-04-03

Start date

2015-04-30

Completion date

2016-03-31

Last updated

2015-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Conscious Sedation, Dormicum

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.

Interventions

DRUGMidazolam

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Months to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Israel

Contacts

Primary ContactMuriel Konopnicki

MurielKo2@clalit.org.il972-4-8250240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026