Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults

Mohsen Saidinejad

Status and phase: Enrolling; Phase 2

Conditions: Vaso-Occlusive Crises; Pain Management; Vaso-Occlusive Pain Episode in Sickle Cell Disease; Ketamine Infusion; Sickle Cell Disease

Treatments: Drug: Normal Saline Placebo Infusion; Drug: Sub-dissociative Ketamine Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07369024

2024-33412-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 5 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Sub-dissociative Ketamine

Experimental group

Description:

Participants receiving 0.25 mg/kg infusion of ketamine

Treatment:

Drug: Sub-dissociative Ketamine Infusion

Normal Saline

Placebo Comparator group

Description:

Participants receiving 100 milliliters of normal saline

Treatment:

Drug: Normal Saline Placebo Infusion