Sickle Cell DiseasePhase 2NCT07369024
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
A Phase 2 study testing Sub-dissociative Ketamine Infusion in people with Sickle Cell Disease and Vaso-Occlusive Pain Episode in Sickle Cell Disease, run by Mohsen Saidinejad at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Ketamine Infusion
- What is being tested?
- Sub-dissociative Ketamine Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to 30 Apr 2028
- Phase
- Phase 2
- 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 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohsen Saidinejad, MD contact
United States1 site, 1 recruiting
- Recruiting
Harbor UCLA Medical Center
Torrance, California, 90509
Cynthia Luo, MD, 310-222-2345, cluo2@dhs.lacounty.gov
Mohsen Saidinejad, MD
About this study
Official title: Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults: A Randomized Control Trial
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.
- Conditions
- Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Ketamine Infusion, Pain Management, Vaso-Occlusive Crises
- Being tested
- Sub-dissociative Ketamine Infusion, Normal Saline Placebo Infusion
- Keywords
- Sickle Cell Disease, Vaso-Occlusive Pain Episode, Sub-Dissociative Ketamine, Pediatric Pain Management
- Medical subject headings
- Anemia, Sickle Cell, Agnosia, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-dissociative Ketamine InfusionDrug
0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
Normal Saline Placebo InfusionDrug
20-minute infusion of 100 milliliters of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Sub-dissociative Ketamine | Experimental | Participants receiving 0.25 mg/kg infusion of ketamine Receives: Drug: Sub-dissociative Ketamine Infusion |
| Normal Saline | Placebo comparator | Participants receiving 100 milliliters of normal saline Receives: Drug: Normal Saline Placebo Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Medications Required for Analgesia
Cumulative morphine-mg equivalent per kilogram (MME/kg) of opioid medication needed to achieve a pain score of ≤ 5
Measured: Up to 3 days
Secondary outcomes (4)
Pain Score
Pain score from 0-10, at 30 and 60 minutes after administration of NS/placebo (control group), versus sub-dissociative ketamine (experimental group)
Measured: 30 minutes and 60 minutes after administration of placebo vs ketamine infusion
ED Length of Stay
To compare ED length of stay between control vs experimental group
Measured: Up to 3 days
Rate of Hospitalization
To compare rate of hospitalization and length of hospitalization between control and experimental group
Measured: Up to 1 month
Quality of Life (Pediatric Quality of Life)
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.
Measured: 7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start10 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohsen Saidinejad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohsen Saidinejad, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369024
- Sponsor's protocol ID
- 2024-33412-01
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07369024
- Acronym / sponsor ID
- 2024-33412-01
- Conditions
- Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Ketamine Infusion, Pain Management, Vaso-Occlusive Crises
- Keywords
- Sickle Cell Disease, Vaso-Occlusive Pain Episode, Sub-Dissociative Ketamine, Pediatric Pain Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mohsen SaidinejadUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 27 Jan 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 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.
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 |
|---|---|---|
| Sub-dissociative Ketamine | Experimental | Drug: Sub-dissociative Ketamine InfusionParticipants receiving 0.25 mg/kg infusion of ketamine |
| Normal Saline | Placebo comparator | Drug: Normal Saline Placebo InfusionParticipants receiving 100 milliliters of normal saline |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| Sub-dissociative Ketamine Infusion0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS) | Drug | Sub-dissociative Ketamine |
| Normal Saline Placebo Infusion20-minute infusion of 100 milliliters of normal saline | Drug | Normal Saline |
Primary outcome
Total Opioid Medications Required for Analgesia
Time frame: Up to 3 days
Cumulative morphine-mg equivalent per kilogram (MME/kg) of opioid medication needed to achieve a pain score of ≤ 5
4 secondary outcomes
Pain Score
Time frame: 30 minutes and 60 minutes after administration of placebo vs ketamine infusion
ED Length of Stay
Time frame: Up to 3 days
Rate of Hospitalization
Time frame: Up to 1 month
Quality of Life (Pediatric Quality of Life)
Time frame: 7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study
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 2 Sep 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.
Mohsen Saidinejad, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sub-dissociative Ketamine Infusion in people with Sickle Cell Disease and Vaso-Occlusive Pain Episode in Sickle Cell Disease, run by Mohsen Saidinejad 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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 2 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Cynthia Luo, MD (310-222-2345, cluo2@dhs.lacounty.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Medications Required for Analgesia (time frame: Up to 3 days). 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 2 Sep 2026.