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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 : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Intervention Drug: ketamine
Enrollment 3
Recruitment Details Three patients were recruited from the sickle cell population from PI's clinic and the hematology/oncology clinic
Pre-assignment Details There were no pre-assignment details
Arm/Group Title Procedure for Administering Ketamine to SCDpatients
Hide Arm/Group Description

This group will receive ketamine

ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.

Dosing Regimen:

  • All patients will begin the ketamine infusion at 0.05 mg/kg/hour.
  • 4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:

    1. the patient's pain has not improved to an acceptable level (pain score is still ≥5)
    2. side effects remain acceptable
  • 4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
  • 4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
  • The maximum dose of ketamine will be limited to 300 mg per 24 hours

The patient may receive ketamine up to 72 hours after initiation.

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Protocol for Administering Ketamine to Patients
Hide Arm/Group Description

This group will receive ketamine

ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.

Dosing Regimen:

  • All patients will begin the ketamine infusion at 0.05 mg/kg/hour.
  • 4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:

    1. the patient's pain has not improved to an acceptable level (pain score is still ≥5)
    2. side effects remain acceptable
  • 4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
  • 4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
  • The maximum dose of ketamine will be limited to 300 mg per 24 hours

The patient may receive ketamine up to 72 hours after initiation.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
2
  66.7%
Between 18 and 65 years
1
  33.3%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
1
  33.3%
Not Hispanic or Latino
2
  66.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  66.7%
White
1
  33.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants With Improvement in Pain Scores of >2 Points on the Pain Scale
Hide Description 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.
Time Frame Baseline then daily while inpatient, up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide Arm/Group Description:

This group will receive ketamine

ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.

Dosing Regimen:

  • All patients will begin the ketamine infusion at 0.05 mg/kg/hour.
  • 4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:

    1. the patient's pain has not improved to an acceptable level (pain score is still ≥5)
    2. side effects remain acceptable
  • 4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
  • 4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
  • The maximum dose of ketamine will be limited to 300 mg per 24 hours

The patient may receive ketamine up to 72 hours after initiation.

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
2.Secondary Outcome
Title Number of Participants Who Showed a Reduction of Opioid Utilization While on IV Ketamine
Hide Description 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.
Time Frame Baseline then daily while inpatient, up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide Arm/Group Description:

This group will receive ketamine

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:

  • 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:

    1. patient's pain has not improved to an acceptable level
    2. 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.

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
Time Frame Collected over 72 hour period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine
Hide Arm/Group Description

This group will receive ketamine

ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.

Dosing Regimen:

  • All patients will begin the ketamine infusion at 0.05 mg/kg/hour.
  • 4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:

    1. the patient's pain has not improved to an acceptable level (pain score is still ≥5)
    2. side effects remain acceptable
  • 4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
  • 4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
  • The maximum dose of ketamine will be limited to 300 mg per 24 hours

The patient may receive ketamine up to 72 hours after initiation.

All-Cause Mortality
Ketamine
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine
Affected / at Risk (%)
Total   0/3 (0.00%) 
Early termination leading to small number of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. William T. Zempsky
Organization: Connecticut Children's Medical Center
Phone: 860-837-5207
EMail: wzempsk@ConnecticutChildrens.org
Layout table for additonal information
Responsible Party: William Zempsky, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00595530     History of Changes
Other Study ID Numbers: 07-101
First Submitted: December 27, 2007
First Posted: January 16, 2008
Results First Submitted: July 27, 2015
Results First Posted: March 30, 2016
Last Update Posted: August 21, 2019