Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims:

Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state and time to onset of minimal sedation associated with each dose.

Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborators: Emergency Medicine Foundation; Mailman School of Public Health
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Ages 6 months to 7 years old (i.e. before their 8th birthday)

• Simple laceration

• Attending physician has decided intranasal midazolam indicated to facilitate repair

Exclusion Criteria:

• Repair using tissue adhesive (e.g. Dermabond) or staples

• Known or confirmed developmental delay

• Baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy)

• Autism spectrum disorder

• Illness associated with chronic pain

• Known allergy to midazolam or any other benzodiazepine

• Eyelid laceration

• Tongue or intraoral lacerations

• Nasal obstruction that cannot be easily cleared

• Does not speak English or Spanish

• Foster children, wards of the state