Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis

NCT07682662 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: UMMC-IRB-2026-154
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sickle Cell Disease (SCD); Vaso-Occlusive Pain Episode in Sickle Cell Disease

Keywords

Pain dosed ketamine; pediatric sickle cell pain crisis; Ketamine in sickle cell pain; sickle cell pain

Outcome Measures

Primary Outcomes (1)

• Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids.

  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.

  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.

  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.

  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.

  From time of patient enrollment and IRB approval until 36 months

• Adverse events experienced after using a Ketamine first pathway

  From time of patient enrollment and IRB approval until 36 months.

Study Arms (2)

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.

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

Other: Standard Care (in control arm)

Interventions

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.

Any patient with confirmed Sickle Cell Disease in pain crisis.

Standard Care (in control arm) OTHER

Standard Care in Historical Control Group

Retrospective Historical Control Group

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Confirmed Sickle Cell Disease (any genotype), Presenting to the Emergency Department with Vaso-occlusive crisis/pain crisis, Consent obtained

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center, Pediatric Emergency Department

Jackson, Mississippi, 39216, United States

Location

Related Publications (12)

• 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.

  PMID: 36861789 BACKGROUND

• Onyebuchi 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.

  PMID: 38000561 BACKGROUND

• Calderon 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

  BACKGROUND

• 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.

  PMID: 35708641 BACKGROUND

• Sener 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.

  PMID: 20970888 BACKGROUND

• Laskowski 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.

  PMID: 21773855 BACKGROUND

• Niesters 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.

  PMID: 23432384 BACKGROUND

• Lovett 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.

  PMID: 25060254 BACKGROUND

• Yawn 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.

  PMID: 25203083 BACKGROUND

• Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.

  PMID: 16508405 BACKGROUND

• Zhang 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.

  PMID: 26758915 BACKGROUND

• Manwani 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.

  PMID: 24052549 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Health Services Needs and Demand; Standard of Care

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• John N Freeman, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Karlson, Ph.D.

CONTACT

601-984-2723; ckarlson@umc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice-Chair for Pediatric Research

Model Details: Mixed retrospective-prospective, single-center, non-randomized pragmatic pilot study of a standardized ketamine analgesia pathway

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)