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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT02801292
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients (\> 3 yrs and \<18yrs) with a previous diagnosis of sickle cell disease (including Hgb S Beta Thalassemia +, Hgb S Alpha Thalassemia, Hgb S HPFH) ) seen in the pediatric emergency room setting for acute vaso-occlusive pain crisis.
Exclusion Criteria:
* Patients not to have sequelae indicative of complicated disease outside of acute VOC:
1. Acute chest syndrome (new pulmonary infiltrate and hypoxemia)
2. Aplastic Episode
3. Evidence of infection
4. Pregnancy or CHF
5. Fever (\> 38.4)
6. Cholangitis or cholecystitis
7. Hypoxia (SaO2 \<90% on RA), or O2 saturation decrease of more than 5% from patient's baseline
8. Unstable Vital Signs
9. Patients who have received intravenous pain medicine within 24 hours of visit to the emergency department.
10. History of allergic reaction or serious reaction to Ketamine.
11. History of significant psychiatric illness
12. Patients with no refractory pain after receiving conventional analgesia regimen per protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT02801292
Study Brief:
Protocol Section:
NCT02801292