Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Treatments: Ketamine

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.