Sickle Cell Crisis, Sickle Cell Disease
Conditions
Keywords
sickle cell disease, ketamine, pain
Brief summary
The goal of this clinical trial is to learn if the use of early ketamine decreases the chance of admission to the hospital in patients with sickle cell disease presenting with pain. The main questions this study aims to answer are: * Does ketamine given within 1 hour of acute care presentation decrease the chance of hospital admission? * If admitted, does continuing ketamine in the first few hours of admission decrease opioid use or length of stay compared to those who start it later in the admission? Researchers will compare the study arm to patients with sickle cell disease who receive placebo within 1 hour of presentation for the first aim. Participants will be given ketamine/placebo by mouth without 1 hour of presentation. If admitted, all participants will be able to start open label IV ketamine upon admission to the floor based on their clinical needs. Participants who end up starting ketamine will be reviewed to determine if early start to ketamine is helpful in reducing opioid use and length of stay.
Interventions
The drug will be compounded using Ketamine vial 10mg/ml. Either the participant will take one Listerine strip prior to drinking the ketamine injection solution and one Listerine strip after or the participant will drink a mixture of cherry syrup and ketamine injection solution together.
OTHERPlacebo
The placebo will be prepared sterile water for a total matching volume of what the ketamine solution would have been. Either the participant will take one Listerine strip prior to drinking the ketamine injection solution and one Listerine strip after or the participant will drink a mixture of cherry syrup and ketamine injection solution together.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* sickle cell disease diagnosis * presenting with pain to ED or infusion clinic * patient at study site * 6 to 24 years old
Exclusion criteria
* allergy to ketamine * severe side effects associated with ketamine * unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants admitted to the hospital from ED or infusion clinic | Within 6 hours of presentation | Investigators will assess the effect of a single dose of oral ketamine compared to placebo administered within one hour of presentation on the percentage of participants admitted to the inpatient hospital unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores on brief surveys for satisfaction and side effects | within 6 hours of receiving study drug/placebo (upon discharge from ED/Infusion) | Investigators will assess the participant or guardian's satisfaction with pain treatment experience using a brief 2 question survey. Low scores are worse than high scores (min 0 and max is 5 for each question) 1\. Please rate participant satisfaction with how well the study drug/placebo helped to relieve participant pain. (0 = Very Dissatisfied; 1 = dissatisfied; 2 = somewhat dissatisfied; 3 = somewhat satisfied; 4 = satisfied; 5=Very Satisfied) 2. Please rate how bothersome each of the following side effects were with the drug participant received If participant did not experience a side effect, please select, "Did not experience". (0=Extremely bothersome; 1 = bothersome; 2 = somewhat bothersome; 3 = mildly bothersome; 4 = not bothersome; 5 = Did not experience) Dysphoria, Dizziness, Unpleasant dreams, Hallucinations, Headache, Nausea, Other |
| Numerical Pain Rating Scale Scores | within 6 hours | Investigators will assess summed pain intensity difference (SPID) in numerical pain rating scale scores between study drug/placebo. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "worst pain imaginable"). 0 is the best outcome and 10 is the worst outcome. |
Countries
United States
Contacts
CONTACTNatasha Archer, MD, MPH
PRINCIPAL_INVESTIGATORNatasha Archer
Boston Children's Hospital
Outcome results
None listed