Sickle Cell DiseasePhase 3NCT07450430
Optimal Timing of Ketamine Initiation for SCD Pain
A Phase 3 study testing Ketamine hydrochloride injection in people with Sickle Cell Disease and Sickle Cell Crisis, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 years
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Crisis
- What is being tested?
- Ketamine hydrochloride injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2026to Feb 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- sickle cell disease diagnosis
- presenting with pain to ED or infusion clinic
- patient at study site
- 6 to 24 years old
Who cannot join
- allergy to ketamine
- severe side effects associated with ketamine
- unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Brookline, Massachusetts, 02445
Natasha Archer, 617-632-3023, natasha.archer@childrens.harvard.edu
About this study
Official title: Double-blind, Randomized, Placebo Controlled Study to Evaluate Optimal Timing of Ketamine Initiation
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:
Read more
- 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.
- Conditions
- Sickle Cell Disease, Sickle Cell Crisis
- Being tested
- Ketamine hydrochloride injection, Placebo
- Keywords
- sickle cell disease, ketamine, pain
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine hydrochloride injectionDrug
Also called Oral ketamine
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Ketamine | Experimental | Single dose of oral ketamine 0.5mg/kg (max dose of 35mg) Receives: Drug: Ketamine hydrochloride injection |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 6 hours of presentation
Secondary outcomes (2)
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)
- 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
Measured: 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.
Measured: within 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Archer, Boston Children's Hospital
- Investigators
- Natasha Archer, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450430
- Sponsor's protocol ID
- P00047716
- Status last verified
- Dec 2025
- First submitted
- 13 Jan 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo Controlled Study to Evaluate Optimal Timing of Ketamine Initiation
- ClinicalTrials.gov ID
- NCT07450430
- Acronym / sponsor ID
- P00047716
- Conditions
- Sickle Cell Disease, Sickle Cell Crisis
- Keywords
- sickle cell disease, ketamine, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Ketamine | Experimental | Drug: Ketamine hydrochloride injectionSingle dose of oral ketamine 0.5mg/kg (max dose of 35mg) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- sickle cell disease diagnosis
- presenting with pain to ED or infusion clinic
- patient at study site
- 6 to 24 years old
Key exclusion criteria (3 listed)
- allergy to ketamine
- severe side effects associated with ketamine
- unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine hydrochloride injectionAlso: Oral ketamineThe 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. | Drug | Oral Ketamine |
| PlaceboThe 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. | Other | Placebo |
Primary outcome
Percentage of participants admitted to the hospital from ED or infusion clinic
Time frame: 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
2 secondary outcomes
Scores on brief surveys for satisfaction and side effects
Time frame: within 6 hours of receiving study drug/placebo (upon discharge from ED/Infusion)
Numerical Pain Rating Scale Scores
Time frame: within 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natasha Archer principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine hydrochloride injection in people with Sickle Cell Disease and Sickle Cell Crisis, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Archer, MD, MPH (617-355-6000 ext. x8246, natasha.archer@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants admitted to the hospital from ED or infusion clinic (time frame: Within 6 hours of presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.