Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain
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ClinicalTrials.gov Identifier: NCT00595530 |
Recruitment Status
:
Terminated
(Lack of enrollment and patient interest in study)
First Posted
: January 16, 2008
Results First Posted
: March 30, 2016
Last Update Posted
: March 30, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sickle Cell Disease | Drug: ketamine | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Use of Low-Dose Ketamine Infusion in Acute Painful Episodes of Sickle Cell Disease: A Pilot Study |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Ketamine
This group will receive ketamine
|
Drug: ketamine
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:
Patient may receive ketamine up to 72 hrs after initiation. Other Name: Ketalar
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- The Number of Participants That Experience Side Effects [ Time Frame: Daily while inpatient and once a week for first 4 weeks post discharge ]How many participants experienced side effects while undergoing treatment with the study drug?
- Intravenous Opiate Utilization [ Time Frame: Every 4 hours ]
- Self-reported Pain Scores [ Time Frame: Every 4 hours ]

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Ages Eligible for Study: | 7 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595530
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030 | |
Connecticut Children's Medical Center | |
Hartford, Connecticut, United States, 06106 |
Principal Investigator: | William T Zempsky, MD | Connecticut Children's Medical Center |
Responsible Party: | William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical Center |
ClinicalTrials.gov Identifier: | NCT00595530 History of Changes |
Other Study ID Numbers: |
07-101 |
First Posted: | January 16, 2008 Key Record Dates |
Results First Posted: | March 30, 2016 |
Last Update Posted: | March 30, 2016 |
Last Verified: | February 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no plan to share data as the low enrollment makes the results of this study non-generalizable. |
Keywords provided by William Zempsky, MD, Connecticut Children's Medical Center:
ketamine vasoocclusive pain |
Additional relevant MeSH terms:
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |