Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: ketamine
Intervention description: Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr.
Dosing Regimen:
Patients begin the ketamine infusion at 0.05 mg/kg/hr.
4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if:
patient's pain has not improved to an acceptable level
side effects remain acceptable
4 hrs or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hr
4 hrs or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
Maximum dose of ketamine is limited to 300 mg per 24 hrs
Patient may receive ketamine up to 72 hrs after initiation.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No
Keywords: ketamine; vasoocclusive pain

Summary:

      Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage
      effectively. Opioid tolerance and side effects have been major roadblocks in our ability to
      provide these patients with adequate pain relief. This pilot study is designed to examine the
      safety and feasibility of using ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist,
      in the inpatient seeing with children and adolescents who have sickle cell vasoocclusive
      pain. Previous research suggests that in subanesthetic doses, ketamine may be able to prevent
      the development of opiate tolerance and facilitate better pain relief with lower opiate
      doses, allowing for less respiratory depression, less sedation, easier ambulation, less
      deconditioning, shorter hospital stays, and better quality of life. The goal of this pilot
      study is to evaluate the safety and feasibility of using a continuous infusion of ketamine,
      in conjunction with opiates, in the inpatient setting for sickle cell vasoocclusive pain. It
      is hypothesized that using a low dose ketamine infusion in conjunction with opiates will be a
      safe and feasible practice for the treatment of sickle cell pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CCMC: Children ages 7-22 years (inclusive) with documented sickle cell disease

          -  UCHC: Adults 18 years (inclusive) and above with documented sickle cell disease

          -  Sudden onset of acute pain consistent with a vasoocclusive episode -Pain requiring
             hospitalization, placement on pain protocol, and patient- controlled opiates

          -  Pain score of greater than or equal to 5 out of 10 when ketamine infusion is started

          -  Cognitive ability to report pain on a 0 to 10 Numerical Rating Scale (NRS)

          -  At least one prior hospitalization for vasoocclusive pain at CCMC in the previous 24
             months

          -  Parental consent and child assent

        Exclusion Criteria:

          -  Children hospitalized for a primary diagnosis other than vasoocclusive episode

          -  Concurrent Acute Chest Syndrome (ACS)

          -  Hemoglobin < 5 mg/dL

          -  Concurrent history of glaucoma or raised intracranial pressure

          -  Signs or symptoms consistent with stroke

          -  History of liver or renal dysfunction

          -  Pregnancy (females age 12 and above must have pregnancy test)

          -  Simultaneous participation in investigational drug study

          -  Primary language spoken other than English

          -  No hospitalizations to CCMC for vasoocclusive pain in the previous 24 months