Menu
Recruiting NCT07369024

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

Phase II Interventional Sickle Cell Disease Vaso-Occlusive Pain Episode in Sickle Cell Disease Ketamine Infusion Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sub-dissociative Ketamine Infusion, Normal Saline Placebo Infusion.
Who it may be relevant to
Registry conditions: Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Ketamine Infusion, Pain Management. Basic parameters: 5 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults: A Randomized Control Trial

Overview

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.

Interventions

  • Drug Sub-dissociative Ketamine Infusion
    0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
  • Drug Normal Saline Placebo Infusion
    20-minute infusion of 100 milliliters of normal saline

Primary outcome measures

  • Total Opioid Medications Required for Analgesia [Time frame: Up to 3 days]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Harbor UCLA Medical Center — Torrance

Identifiers

NCT: NCT07369024 · 2024-33412-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗