Recruiting
Phase 2

Ketamine with Opioids

Sponsor:

Mohsen Saidinejad

Code:

NCT07369024

Conditions

Sickle Cell Disease

Vaso-Occlusive Pain Episode in Sickle Cell Disease

Ketamine Infusion

Pain Management

Vaso-Occlusive Crises

Eligibility Criteria

Sex: All

Age: 5 - 20

Healthy Volunteers: Not accepted

Interventions

Sub-dissociative Ketamine Infusion

Normal Saline Placebo Infusion

Study Details

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.

Conditions

Sickle Cell Disease

Vaso-Occlusive Pain Episode in Sickle Cell Disease

Ketamine Infusion

Pain Management

Vaso-Occlusive Crises

Study ID

NCT07369024

Start date

Sep 10, 2026

Status verified date

Mar, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 20

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub-dissociative Ketamine

Participants receiving 0.25 mg/kg infusion of ketamine

placebo comparator: Normal Saline

Participants receiving 100 milliliters of normal saline

Interventions

Sub-dissociative Ketamine Infusion

0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)

Normal Saline Placebo Infusion

20-minute infusion of 100 milliliters of normal saline

Primary outcome measure

  • Total Opioid Medications Required for Analgesia [ Time Frame: Up to 3 days ]

Central Contacts and Locations

Central contacts

Cynthia Luo, MD

310-222-2345cluo2@dhs.lacounty.gov

Mohsen Saidinejad, MD

moh@emedharbor.edu

Locations

Harbor UCLA Medical Center

Recruiting

Torrance, California, United States, 90509

Contacts

Cynthia Luo, MD

310-222-2345cluo2@dhs.lacounty.gov

Principal Investigator:

Mohsen Saidinejad, MD

More Information

Sponsor

Mohsen Saidinejad

Last update posted

Sep 2, 2026

Last verified

Mar, 2026

Keywords

  • Sickle Cell Disease
  • Vaso-Occlusive Pain Episode
  • Sub-Dissociative Ketamine
  • Pediatric Pain Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mohsen Saidinejad on 2026-09-02.