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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Ketamine | Experimental | Single dose of oral ketamine 0.5mg/kg (max dose of 35mg) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine hydrochloride injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants admitted to the hospital from ED or infusion clinic | 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 | Within 6 hours of presentation |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on brief surveys for satisfaction and side effects | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of IV opioid administration days in study drug/placebo groups | Investigators will assess the average number of IV opioid administration days in ketamine versus placebo groups | 30 days of admission |
| Number of participants readmitted to the hospital within 14 days of discharge from ED, infusion clinic, or inpatient unit. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natasha Archer, MD, MPH | Contact | 617-355-6000 | x8246 | natasha.archer@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Natasha Archer | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Brookline | Massachusetts | 02445 | United States |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000098644 | Vaso-Occlusive Crises |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| Placebo | Other | 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. |
|
| within 6 hours of receiving study drug/placebo (upon discharge from ED/Infusion) |
| Numerical Pain Rating Scale Scores | 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. | within 6 hours |
Investigators will assess clinical outcomes related to discharge including readmission to the ED, infusion clinic, or hospital. |
| Within14 days post discharge |
| Length of stay of participants admitted when treated with ketamine/placebo | Investigators will assess the length of stay of admitted participants treated with ketamine versus placebo. | 30 days of admission |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |