- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00595530
Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain
Use of Low-Dose Ketamine Infusion in Acute Painful Episodes of Sickle Cell Disease: A Pilot Study
Study Overview
Detailed Description
3.2 Study Design/Type
- Patient meeting inclusion/exclusion criteria is enrolled up to 24 hours after admission for a vasoocclusive episode.
Prior to onset of ketamine infusion, the following information is collected:
- Demographic information (age, gender, SCD genotype, past history of SCD-related complications) [Obtained from the patient's medical chart]
- Opiate utilization/hour since admission [Obtained from the patient's medical chart]
- Numerical Rating Scale (NRS) scores since admission [Obtained from the patient's medical chart]
- Sedation score (University of Michigan Sedation Scale) is obtained [By the nursing staff]
- Body outline figure of the Adolescent Pediatric Pain Tool (validated down to age 7) is administered [By the research staff]
- Ketamine Effects Scale (KES) is administered to the patient [By the research staff]
- Ketamine infusion is begun at 0.05 mg/kg/hour.
After infusion is initiated:
- Vital signs are taken every hour for two hours after infusion begins, then after two hours, then every four hours for the remainder of the hospitalization [Completed by the nursing staff]
- Pain scores are recorded with vital signs if the patient is awake [Completed by nursing staff]
- Patient is also asked if pain is a lot better, a little better, no change, a little worse, or a lot worse than previous assessment [Completed by nursing staff]
- Sedation score (University of Michigan Sedation Scale) assessed with pain score [Completed by the nursing staff]
- Adolescent Pediatric Pain Tool (APPT) body outline figure is completed by the patient once per day between 3 pm and 5 pm. [Administered by the research staff]
- Ketamine Effects Scale (KES) is administered to the patient once per day between 3pm and 5pm [By the research staff]
- Patient is monitored for side effects including dreams, disorientation, dysphoria, agitation, CNS depression, respiratory depression, increasing hypoxia, nausea, or vomiting [Completed by the nursing or research staff]
- Need for supplemental oxygen is recorded (oxygen saturation <95%) [Completed by nursing staff]
- Opiate use and NSAID use/6 hours is recorded [Completed by the nursing or research staff]
- The infusion may be discontinued or decreased at any time due to unacceptable side effects as determined by the clinician, patient, parent, or principal investigator.
- Agents designed to reduce ketamine side effects [midazolam (Versed), clonidine, lorazepam (Ativan), or diazepam (Valium)] may be administered at the discretion of the attending physician or the principal investigator.
4 hours or more after infusion begins, the infusion rate may be increased to 0.1 mg/kg/hour if the following parameters are met:
- patient's pain has not improved to an acceptable range (pain score is still ≥5)
- side effects remain acceptable
- 4 hours or more after the previous increase the ketamine infusion may be increased to 0.15 mg/kg/hour per parameters.
- 4 hours of more after the previous increase the ketamine infusion may be increased to 0.2 mg/kg/hour per parameters.
- The ketamine infusion will be discontinued at the time of transition to oral pain medication, or no more than 72 hours after initiation, or at the request of the clinician, patient, parent, or principal investigator.
- Pain scores, vital signs, sedation score, opiate use, APPT body outline figure, and KES score will be recorded as above for the remainder of the hospitalization.
- Total length of hospitalization will be recorded.
- Patient will be contacted on a weekly basis for 4 weeks following hospitalization for review of potential side effects, pain episodes, or events leading to re-admission.
- The patient's medical record will be reviewed to determine duration of previous hospitalizations for SCD pain in the previous 24 months and opiate utilization, pain scores, and transition to oral opiates during those hospitalizations.
3.3 Randomization
This will be conducted as a pilot study; patients will not be randomized.
3.4 Duration
The length of the patient's participation in this study is the duration of their hospitalization, as well as 4 weeks worth of follow-up phone calls.
3.5 Discontinuation
Individual patients will stop receiving ketamine if they develop acute chest syndrome (ACS), have a stroke, are transferred to the Intensive Care Unit (ICU), if their hemoglobin falls below 5 mg/dl, if they experience unacceptable side effects, or at the request of the PI, attending, patient, or parent. However, they will continue to be in the study and all data will be collected throughout the duration of their hospitalization.
The entire trial will be terminated when 20 patients have completed the protocol, or if there is an unexpected rate of acute chest syndrome or admissions to the pediatric intensive care unit (PICU).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Connecticut
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Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine
This group will receive 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Improvement in Pain Scores of >2 Points on the Pain Scale
Time Frame: Baseline then daily while inpatient, up to 72 hours
|
Determine if there is an apparent improvement in pain control with the ketamine infusion based on the investigator's discretion and comparison to past pain scores.
Pain was scored on a scale from 0 to 10. Zero equaled no pain and 10 equaled a lot of pain.
|
Baseline then daily while inpatient, up to 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Showed a Reduction of Opioid Utilization While on IV Ketamine
Time Frame: Baseline then daily while inpatient, up to 72 hours
|
Looking at the reduction of opioid utilization while on IV Ketamine.
Three participants were enrolled in the study, therefore a comprehensive analysis could not be done due to the low enrollment.
|
Baseline then daily while inpatient, up to 72 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: William T Zempsky, MD, Connecticut Children's Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Anemia, Sickle Cell
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 07-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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