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

Phase 4

• Conditions: Conscious Sedation; Dormicum; Children
• Interventions: Drug: Midazolam

• Registration Number: NCT02408302
• Lead Sponsor: Carmel Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-31
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral midazolam	Midazolam	oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.
intranasal midazolam	Midazolam	intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
buccal midazolam	Midazolam	buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel