Vaso-Occlusive Pain Episode in Sickle Cell DiseasePhase 4NCT07682662
Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis
A Phase 4 study testing Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses. in people with Vaso-Occlusive Pain Episode in Sickle Cell Disease and Sickle Cell Disease (SCD), run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Vaso-Occlusive Pain Episode in Sickle Cell Disease, Sickle Cell Disease (SCD)
- What is being tested?
- Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Oct 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed Sickle Cell Disease (any genotype), Presenting to the Emergency Department with Vaso-occlusive crisis/pain crisis, Consent obtained
Who cannot join
- Ketamine allergy, Severe agitation/psychosis, Pregnancy, Hemodynamic instability (as judged by physician), Increased intracranial pressure, Severe hepatic impairment, Ketamine use within the previous 24 hours, Presentation for non-VOC-related pain (i.e. fever, acute chest syndrome, stroke, traumatic injuries etc).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Mississippi Medical Center, Pediatric Emergency Department
Jackson, Mississippi, 39216
Cynthia Karlson, Ph.D., 601-984-2723, ckarlson@umc.edu
Elizabeth Adeyemi, MD
About this study
Official title: Evaluation of a Standardized Low-Dose Bolus Ketamine Pathway for Management of Pediatric Sickle Cell Patients Presenting to the Emergency Department With Pain
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses., Standard Care (in control arm)
- Keywords
- Pain dosed ketamine, pediatric sickle cell pain crisis, Ketamine in sickle cell pain, sickle cell pain
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses.Drug
This dosing is based off of Ideal body weight of each patient and dosed at 0.3 mg/kg/dose.
Standard Care (in control arm)Other
Standard Care in Historical Control Group
| Study group | Role | What they receive |
|---|---|---|
| Any patient with confirmed Sickle Cell Disease in pain crisis. | Experimental | 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. Receives: 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 | Retrospective Historical Control Group Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids.
Measured: From time of patient enrollment and IRB approval for 36 months
Secondary outcomes (5)
Emergency Department length of stay after using the Ketamine first pathway.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From time of patient enrollment and IRB approval until 36 months
Adverse events experienced after using a Ketamine first pathway
Measured: From time of patient enrollment and IRB approval until 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Vaso-Occlusive Pain Episode in Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Mixed retrospective-prospective, single-center, non-randomized pragmatic pilot study of a standardized ketamine analgesia pathway
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Karlson, University of Mississippi Medical Center
- Investigators
- John N Freeman, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682662
- Sponsor's protocol ID
- UMMC-IRB-2026-154
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Our data will remain on a secured REDCAP. De-identified data may be shared upon reasonable request.
Publications
Harris EM, Vilk E, Donado C, Williams A, Heeney MM, Solodiuk J, Greco C, Archer NM. Ketamine use for management of vaso-occlusive pain in pediatric sickle cell disease. Pediatr Blood Cancer. 2023 May;70(5):e30254. doi: 10.1002/pbc.30254. Epub 2023 Mar 2.
PubMed 36861789Onyebuchi CO, Chumpitazi CE, Placencia JL, Jackson AN, Jones JL, Torres L, Tubman VN. Ketamine for Pain in Sickle Cell Disease Reduces Opioid Usage. J Pain Symptom Manage. 2024 Mar;67(3):e169-e175. doi: 10.1016/j.jpainsymman.2023.11.012. Epub 2023 Nov 23.
PubMed 38000561Calderon Martinez E, Saji SZ, Carmona TC, et al. Ketamine for pain relief in sickle cell vaso-occlusive crises: a systematic review. Blood. 2024;144(Suppl 1):5356. doi:10.1182/blood-2024-211793. Abstract for the 66th ASH Annual Meeting
Kenney MO, Becerra B, Mallikarjunan A, Shah N, Smith WR. Early Initiation of Sub-Anesthetic Ketamine Infusion in Adults with Vaso-Occlusive Crises Is Associated with Greater Reduction in Sickle Cell Pain Intensity: A Single Center's Experience. Pain Med. 2022 Dec 1;23(12):2042-2049. doi: 10.1093/pm/pnac094.
PubMed 35708641Sener S, Eken C, Schultz CH, Serinken M, Ozsarac M. Ketamine with and without midazolam for emergency department sedation in adults: a randomized controlled trial. Ann Emerg Med. 2011 Feb;57(2):109-114.e2. doi: 10.1016/j.annemergmed.2010.09.010.
PubMed 20970888Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.
PubMed 21773855Niesters M, Martini C, Dahan A. Ketamine for chronic pain: risks and benefits. Br J Clin Pharmacol. 2014 Feb;77(2):357-67. doi: 10.1111/bcp.12094.
PubMed 23432384Lovett PB, Sule HP, Lopez BL. Sickle cell disease in the emergency department. Emerg Med Clin North Am. 2014 Aug;32(3):629-47. doi: 10.1016/j.emc.2014.04.011. Epub 2014 Jun 7.
PubMed 25060254Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517.
PubMed 25203083Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.
PubMed 16508405Zhang D, Xu C, Manwani D, Frenette PS. Neutrophils, platelets, and inflammatory pathways at the nexus of sickle cell disease pathophysiology. Blood. 2016 Feb 18;127(7):801-9. doi: 10.1182/blood-2015-09-618538. Epub 2016 Jan 12.
PubMed 26758915Manwani D, Frenette PS. Vaso-occlusion in sickle cell disease: pathophysiology and novel targeted therapies. Blood. 2013 Dec 5;122(24):3892-8. doi: 10.1182/blood-2013-05-498311. Epub 2013 Sep 19.
PubMed 24052549