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:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT00205712
Eligibility Criteria:
Inclusion Criteria:
Patients presenting to St. Louis Children's Hospital's Emergency Department who require reduction of an acute forearm fracture will be recruited for enrollment if they satisfy the following:
1. Age 7-17 years, inclusive;
2. Are psychiatrically healthy (i.e. have never been under the care of a psychiatrist or taken psychiatrically active medications);
3. Meet American Society of Anesthesiologist (ASA) Class I and II criteria (I=healthy, II=chronic disease under good control);
4. Have had no prior fracture reduction or ketamine administration;
5. Present for care when research assistants are present (Monday-Friday, 09:00-23:00); and
6. Have a home telephone or ready means of establishing telephone contact.
All subjects and their parent/guardian will give Washington University Human Studies Committee approved written informed assent and consent prior to participation.
Exclusion Criteria:
1. Solid food intake 2 hours or less before procedure;
2. Compromised cardiorespiratory function; central nervous system, hepatic, or renal abnormality;
3. History of psychosis in patient or first degree relative;
4. Currently taking medications that stimulate or depress mental function, e.g. methylphenidate for attention deficit hyperactivity disorder or drugs of abuse;
5. History of allergy or adverse reaction to alpha-2 adrenoreceptor agonist drugs, e.g. clonidine.
These exclusion criteria relate to contraindications for use of the agents employed in the study. Criteria 1, 2, 3 and 4 are current routine practice for ketamine sedations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT00205712
Study Brief:
Protocol Section:
NCT00205712