Ketamine Infusion, Pain Management, Sickle Cell Disease, Vaso-Occlusive Crises, Vaso-Occlusive Pain Episode in Sickle Cell Disease
Conditions
Keywords
Sickle Cell Disease, Vaso-Occlusive Pain Episode, Sub-Dissociative Ketamine, Pediatric Pain Management
Brief summary
The purpose of this research is to see if ketamine is effective and safe in treating children and young adults with sickle cell disease experiencing sickle cell related pain. In this study, we will compare the outcomes (such as pain scores) in persons who receive standard of care pain medicine (an opioid such as morphine) plus a low dose (amount) of ketamine to those who receive only standard of care pain medicine.
Interventions
DRUGSub-dissociative Ketamine Infusion
0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
20-minute infusion of 100 milliliters of normal saline
Sponsors
Mohsen Saidinejad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages 5-20 years * Diagnosed sickle cell disease. Homozygous (HbSS) or heterozygous (HbSC, HbSBetaThal Plus or Zero) will be included. * Presenting with VOE pain, requiring IV pain medication. * First dose of analgesic medication is given before patient approached for participation in the study. * Primary language is English or Spanish * Adult individual or parent/legal guardian is able and willing to provide informed consent. For individuals 7 to 17 years of age, assent must also be provided when cognitively possible.
Exclusion criteria
* Sickle cell trait only * Patients whose primary language is other than English or Spanish * Pain attributed to causes other than VOE * Not requiring IV for pain treatment * No analgesic (e.g. opiate) is given before approach for study participation due to any reason, including problem with IV access. * Oxygen saturation \< 90% on room air * History of prior adverse reaction to ketamine * History of hypertension - Patients with active/uncontrolled hypertension defined as systolic 140 mmHg over diastolic of 90 mmHg will be excluded from participation in the study. If hypertension is controlled and at the time of enrollment, systolic and diastolic thresholds of 140 mmHg and 90 mmHg respectively are not exceeded, patient may be included in the study * History of significant or uncontrolled cardiovascular disease, liver disease, kidney disease, and thyroid disease * Patients with evidence of increased intracranial pressure * Patients with elevated intraocular pressure * Patients with acute mania or history of bipolar disorder with manic episodes, history of hallucinations or paranoia secondary to previously diagnosed psychiatric condition * Pregnant or potentially pregnant patients per patient report. All patients of childbearing potential will undergo pregnancy testing prior to enrollment (as part of clinical care), and if positive, will be excluded. * Elevated liver enzymes (alkaline phosphatase, ALT, AST, bilirubin) as sign of hepatic disfunction if the laboratory results are available prior to study participation * Patients who appear intoxicated on any substance. * Patients who are wards of the state or prisoners as defined by DHS * Patients who are not deemed to be competent to provide consent or assent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Medications Required for Analgesia | Up to 3 days | Cumulative morphine-mg equivalent per kilogram (MME/kg) of opioid medication needed to achieve a pain score of ≤ 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 30 minutes and 60 minutes after administration of placebo vs ketamine infusion | Pain score from 0-10, at 30 and 60 minutes after administration of NS/placebo (control group), versus sub-dissociative ketamine (experimental group) |
| ED Length of Stay | Up to 3 days | To compare ED length of stay between control vs experimental group |
| Rate of Hospitalization | Up to 1 month | To compare rate of hospitalization and length of hospitalization between control and experimental group |
| Quality of Life (Pediatric Quality of Life) | 7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study | To compare overall quality of life between the two groups upon discharge from the ED or the hospital, using the Pediatric Quality of Life (PedsQL) questionnaire. The questionnaire has 43 points and is reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better quality of life. |
Countries
United States
Contacts
CONTACTCynthia Luo, MD
CONTACTMohsen Saidinejad, MD
Outcome results
None listed