Ketamine Infusion for Sickle Cell Pain Crisis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04005209|
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anemia; Sickle-Cell, With Crisis Acute Pain||Drug: Ketamine Other: Pain management||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||January 1, 2021|
Active Comparator: Pain management without ketamine infusion
Pain management without ketamine infusion. No other restrictions on pain management or medications.
Other: Pain management
Experimental: Pain management with ketamine infusion
Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.
The experimental group will receive a ketamine intravenous infusion, initiated at 0.2 mg/kg/hr within the first 12 to 24 hours on an inpatient admission for sickle cell pain crisis, and titrated per hospital policy by the inpatient pain service.
Other: Pain management
- Percentage reduction in grand mean opioid consumption from 0 to 72 hours [ Time Frame: baseline, 72 hours ]
- Percentage reduction in grand mean pain score using the 11-point visual analog scale [ Time Frame: baseline, 72 hours ]Using standard 11-point visual analog pain scale, ranging from 0 = no pain to 10 = worst pain imaginable.
- Time from inpatient admission to readiness for discharge [ Time Frame: Upon discharge from the hospital (an average of 1 week) ]
- 30-day hospital readmission rate [ Time Frame: 30 days from discharge ]
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): NCT04005209
|Contact: Neil Ray, MDfirstname.lastname@example.org|
|Contact: David W Creighton, MDemail@example.com|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: David W Creighton, MD firstname.lastname@example.org|
|Contact: Neil Ray, MD email@example.com|
|Sub-Investigator: David W Creighton, MD|
|Sub-Investigator: Nirmish Shah, MD|
|Principal Investigator: Neil Ray, MD|
|Sub-Investigator: Milly Rambhia, MD|
|Sub-Investigator: Elizabeth Gauthier, MD|
|Sub-Investigator: Christian Horazeck, MD|