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

Columbia University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Procedural Anxiety

Treatments: Drug: Intranasal midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT04586504

AAAS7996

Details and patient eligibility

About

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 associated with each dose.

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

Full description

Intranasal midazolam is a common and effective sedative whose use in children presenting to emergency departments has been described. However, the doses of intranasal midazolam used have varied greatly, with no identified optimal dose. Doses most commonly described in literature reviews, research studies, and clinical guidelines range from 0.2 to 0.5 mg/kg. There is only one study, retrospective, that compares doses and suggests that clinical efficacy is improved with higher doses, without any clear difference in safety. There is a need for a rigorously-conducted trial to determine the dose of intranasal midazolam that optimizes the adequacy of sedation state without leading to adverse events or compromising emergency department-centric outcomes such as time to onset of sedation and time to recovery. To fill this important and persistent gap in knowledge, the investigator will conduct a dose-finding study using an adaptive trial design to compare intranasal midazolam doses of 0.2, 0.3, 0.4, and 0.5 mg/kg in children undergoing laceration repairs, one of the most common types of minor trauma treated in emergency departments.

Enrollment: 101 patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 4 patient groups

0.2 mg/kg

Experimental group

Description:

Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.

Treatment:

Drug: Intranasal midazolam

0.3 mg/kg

Experimental group

Description:

Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.

Treatment:

Drug: Intranasal midazolam

0.4 mg/kg

Experimental group

Description:

Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.

Treatment:

Drug: Intranasal midazolam

0.5 mg/kg

Experimental group

Description:

Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.

Treatment:

Drug: Intranasal midazolam