CompletedPhase 1/2

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

United States101 participantsStarted 2021-09-08

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

Who can participate

Age range

6 Months – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Children Who Achieved PSSS Score 2, 3, or 4 for 95% or Greater of the Scored Procedure

Timeframe: From study drug administration until procedure finished (approximately 60 minutes)

Trial details

NCT IDNCT04586504

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-14

Results submitted2025-05-28

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