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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT05934669
Eligibility Criteria:
Inclusion Criteria:
* Age 1-5 years old
* Presents to the ED for suture repair for lacerations less than or equal to 5cm in length
* Parent(s)/Caregiver(s) speak English
Exclusion Criteria:
* Younger than 12 months of age or older than 5 years old
* Suture repair needed for lacerations are greater than 5cm in length
* Known allergy or adverse effect to Midazolam, Dexmedetomidine, Ketamine, or any other sedatives
* Any abnormal vital signs for age, especially heart rate and blood pressure
* History of Cardiac, respiratory, renal, or liver disease
* Known electrolyte abnormalities
* Any ocular trauma, nasal injury, nasal deformity, significant nasal congestion, abnormalities in the nasal or oral mucosa, facial deformity, or facial injury
* Home medications include beta blockers or any other blood pressure lowering agents Classified American Society of Anesthesiologists III and above
* Known or anticipated difficult airway
* Abnormal neurological exam
* Parent(s)/Caregiver(s) do not speak English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
5 Years
Study:
NCT05934669
Study Brief:
Protocol Section:
NCT05934669