Sickle Cell Disease
Conditions
Brief 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).
Detailed description
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). Our study design is as follows: Prospective observational study of 20 pediatric sickle cell disease patients with refractory pain to conventional analgesic regimens seen in the pediatric emergency medicine department. Consenting patients with refractory pain meeting inclusion criteria will be given a single intravenous bolus of Ketamine at a set dosage of 0.25 milligrams per kilogram of weight. Participants' perception of pain will then be recorded using standard pain scoring scales (FLACC score). Physiologic criteria such as heart rate, blood pressure, blood oxygen saturation, total analgesic pharmacologic requirements for adequate analgesia during hospitalization, and duration of hospitalization will be measured. Observational study group will continue to get standard of care outside of single bolus of Ketamine. 48 hour follow up after hospital discharge will be obtained to assess degree of pain control and general clinical status.
Interventions
DRUGKetamine
Single bolus of Ketamine .25 milligrams per kilogram of weight.
Sponsors
Augusta University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score | 1 hour | reduction in refractory pain |
Contacts
Primary ContactGeorge Hsu, MD
Backup ContactNatalie Lane, MD
Outcome results
None listed