Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT04586504
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
7 Years
Study:
NCT04586504
Study Brief:
Protocol Section:
NCT04586504