A Phase 4 interventional study of Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses. and Standard Care (in control arm) in Vaso-Occlusive Pain Episode in Sickle Cell Disease and Sickle Cell Disease (SCD), sponsored by University of Mississippi Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of Mississippi Medical Center · Phase 4, Interventional, and Treatment
The goal of this study is to learn if Ketamine works more efficiently, as compared to Opioids, for Sickle Cell Pain The main questions it aims to answer are:
Does Ketamine lower the number of times participants need to be admitted for continued pain control during a Sickle Cell Pain Crisis.
Does Ketamine decrease the amount of time it takes to reach adequate pain control/pain score improvement, as compared to Opioids.
Patients could have too low or too high blood pressure or sleepiness. Researchers will compare Ketamine to Opioids (Morphine or Dilaudid) to see if Ketamine works to treat pain enough that you do not need to be admitted to the hospital.
Participants will:
On arrival to the Children's ER for Sickle Cell Pain crisis will get Ketamine, instead of Morphine or Dilaudid, along with the typical Tylenol, Toradol, Lidocaine patch for pain control while in the ER.
During this time we will follow your reported pain scale (0-10) to monitor your pain response to the Ketamine, as well as follow rate of hospital admission.
In this study, we will be using Ketamine for pain control during a Sickle Cell Disease pain crisis, along with our current adjuncts (Tylenol, Toradol, Lidocaine patch, or heat packs), in hopes to lower the rate of admission to the hospital for continued pain control.
When presenting to the ER for pain crisis the first dose of Ketamine should be given within 30 minutes of arrival to the ER. Prior to giving Ketamine, vitals and current pain scale will be recorded in the chart. The vitals and pain scale will be rechecked every 30 minutes and documented in the chart. If a second or third dose is needed at the one-hour mark, then a second dose will be given. If after the second dose the patient does not report sufficient pain control then a third dose will be given and the patient will be admitted to the hospital.
The patient is free to opt out of the Ketamine pathway at any time and Opioids can be administered.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's planned enrollment of 400 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →University of Mississippi Medical Center is the lead sponsor of 129 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Exclusion Criteria:
This group will be any patient, aged 2 years until 21 years with confirmed sickle cell disease who presents to the Pediatric Emergency Department with Pain will receive multimodal pain control using Acetaminophen, Toradol, lidocaine patch, and heat packs, as well as IV Ketamine in place of Opioids.
Drug: Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses.
Retrospective Historical Control Group
Other: Standard Care (in control arm)
This dosing is based off of Ideal body weight of each patient and dosed at 0.3 mg/kg/dose.
Standard Care in Historical Control Group
Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids.
Time frame: From time of patient enrollment and IRB approval for 36 months
Emergency Department length of stay after using the Ketamine first pathway.
Time frame: From time of patient enrollment and IRB approval until 36 months.
Pain score reduction in the acute setting after using a Ketamine first pathway as compared to Opioid first pathway.
Time frame: From time of patient enrollment and IRB approval until 36 months.
Rate of repeat visits to the Emergency Department within 72 hours for pain after a Ketamine first pathway was followed.
Time frame: From time of patient enrollment and IRB approval until 36 months.
Inpatient length of stay (in number of days) for to reach adequate length of stay.
Time frame: From time of patient enrollment and IRB approval until 36 months
Adverse events experienced after using a Ketamine first pathway
Time frame: From time of patient enrollment and IRB approval until 36 months.
Plan to share: No — Our data will remain on a secured REDCAP. De-identified data may be shared upon reasonable request.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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