Trial Outcomes & Findings for Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain (NCT NCT00595530)

Last Updated: 2019-08-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline then daily while inpatient, up to 72 hours

Results posted on

2019-08-21

Participant Flow

Three patients were recruited from the sickle cell population from PI's clinic and the hematology/oncology clinic

There were no pre-assignment details

Participant milestones

Participant milestones
Measure	Procedure for Administering Ketamine to SCDpatients 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 Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Protocol for Administering Ketamine to Patients n=3 Participants 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.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline then daily while inpatient, up to 72 hours

Outcome measures

Outcome measures
Measure	Ketamine n=3 Participants 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.
Number of Participants With Improvement in Pain Scores of >2 Points on the Pain Scale	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ketamine n=3 Participants 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.
Number of Participants Who Showed a Reduction of Opioid Utilization While on IV Ketamine	3 Participants

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William T. Zempsky

Connecticut Children's Medical Center

Phone: 860-837-5207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place