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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07367659
Eligibility Criteria:
Inclusion Criteria:
* Children aged between 4 and 6 years,
* An intramuscular (IM) medication order was prescribed by a physician,
* The IM injection was administered in the pediatric emergency department,
* No history of chronic pain-causing illness,
* No diagnosis of neurodevelopmental disorders,
* Had not received any analgesic medications in the past 6 hours,
* No history of syncope (fainting) during previous injections,
No diagnosis of mental retardation,
* No scar tissue or muscle atrophy at the intended injection site,
* Body mass index (BMI) percentile between the 10th and 90th percentiles for age and gender,
* Both child and parent provided informed consent to participate in the study.
Exclusion Criteria;
* Participants were excluded from the study if:
* The child was younger than 4 or older than 6 years,
* There was scar tissue or muscle atrophy at the injection site,
* The child or parent had communication difficulties,
* The child's BMI was below the 10th percentile (cachectic) or above the 90th percentile (obese),
* Either the child or parent declined to participate in the research.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
6 Years
Study:
NCT07367659
Study Brief:
Protocol Section:
NCT07367659