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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT05796232
Eligibility Criteria:
Inclusion Criteria:
1. Any child between 1 and 17 years of age needing sedation and analgesia for painful procedures, such as suture laceration, fracture reductions, burn medications, bone marrow aspiration, lumbar puncture, arthrocentesis, colonoscopy and others.
2. Use of intravenous ketamine as the sole sedative agent for the procedure.
Exclusion Criteria:
1. Children needing drugs other that ketamine for sedation, such as fentanyl, propofol, midazolam and dexmedetomidine .
2. Children with intellectual disability or with non typical neurodevelopment, such as children with autism.
3. Children with a history of allergy or hypersensibility to ketamine.
4. Parents limitations in language and understanding informed consent forms and procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT05796232
Study Brief:
Protocol Section:
NCT05796232