[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07682662":3,"trial-entities:NCT07682662":139,"trial-summary:NCT07682662":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":49,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":71,"locations":74,"central_contacts":95,"overall_officials":97,"references":101,"see_also_links":138},"NCT07682662","UMMC-IRB-2026-154","Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis","Evaluation of a Standardized Low-Dose Bolus Ketamine Pathway for Management of Pediatric Sickle Cell Patients Presenting to the Emergency Department With Pain","NOT_YET_RECRUITING","2029-10-01","2026-06","2026-07-06","2026-08-01","University of Mississippi Medical Center","OTHER",false,"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:\n\nDoes Ketamine lower the number of times participants need to be admitted for continued pain control during a Sickle Cell Pain Crisis.\n\nDoes Ketamine decrease the amount of time it takes to reach adequate pain control\u002Fpain score improvement, as compared to Opioids.\n\nPatients 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.\n\nParticipants will:\n\nOn 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.\n\nDuring 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.\n\nWhen 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.\n\nThe patient is free to opt out of the Ketamine pathway at any time and Opioids can be administered.",[19,20],"Vaso-Occlusive Pain Episode in Sickle Cell Disease","Sickle Cell Disease (SCD)",[22,23,24,25],"Pain dosed ketamine","pediatric sickle cell pain crisis","Ketamine in sickle cell pain","sickle cell pain","INTERVENTIONAL","TREATMENT",[29],"PHASE4",{"count":31,"type":32},400,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses.","This dosing is based off of Ideal body weight of each patient and dosed at 0.3 mg\u002Fkg\u002Fdose.",[39],"Any patient with confirmed Sickle Cell Disease in pain crisis.",{"type":14,"name":41,"description":42,"armGroupLabels":43},"Standard Care (in control arm)","Standard Care in Historical Control Group",[44],"Retrospective Historical Control Group",[46],{"measure":47,"timeFrame":48},"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",[50,53,55,57,60],{"measure":51,"timeFrame":52},"Emergency Department length of stay after using the Ketamine first pathway.","From time of patient enrollment and IRB approval until 36 months.",{"measure":54,"timeFrame":52},"Pain score reduction in the acute setting after using a Ketamine first pathway as compared to Opioid first pathway.",{"measure":56,"timeFrame":52},"Rate of repeat visits to the Emergency Department within 72 hours for pain after a Ketamine first pathway was followed.",{"measure":58,"timeFrame":59},"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",{"measure":61,"timeFrame":52},"Adverse events experienced after using a Ketamine first pathway","ALL","2 Years","21 Years",{"inclusion":66,"exclusion":68,"raw_text":70},[67],"Confirmed Sickle Cell Disease (any genotype), Presenting to the Emergency Department with Vaso-occlusive crisis\u002Fpain crisis, Consent obtained",[69],"Ketamine allergy, Severe agitation\u002Fpsychosis, 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).","Inclusion Criteria:\n\n* Confirmed Sickle Cell Disease (any genotype), Presenting to the Emergency Department with Vaso-occlusive crisis\u002Fpain crisis, Consent obtained\n\nExclusion Criteria:\n\n* Ketamine allergy, Severe agitation\u002Fpsychosis, 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).",[72,73],"CHILD","ADULT",[75],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":92},"University of Mississippi Medical Center, Pediatric Emergency Department","Jackson","Mississippi","39216","United States",[82,87,90],{"name":83,"role":84,"phone":85,"email":86},"Cynthia Karlson, Ph.D.","CONTACT","601-984-2723","ckarlson@umc.edu",{"name":88,"role":89},"Elizabeth Adeyemi, MD","SUB_INVESTIGATOR",{"name":91,"role":89},"Laci M Edwards, MD",{"lat":93,"lon":94},32.29876,-90.18481,[96],{"name":83,"role":84,"phone":85,"email":86},[98],{"name":99,"affiliation":13,"role":100},"John N Freeman, MD","PRINCIPAL_INVESTIGATOR",[102,106,109,111,114,117,120,123,126,129,132,135],{"pmid":103,"type":104,"citation":105},"36861789","BACKGROUND","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\u002Fpbc.30254. Epub 2023 Mar 2.",{"pmid":107,"type":104,"citation":108},"38000561","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\u002Fj.jpainsymman.2023.11.012. Epub 2023 Nov 23.",{"type":104,"citation":110},"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\u002Fblood-2024-211793. Abstract for the 66th ASH Annual Meeting",{"pmid":112,"type":104,"citation":113},"35708641","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\u002Fpm\u002Fpnac094.",{"pmid":115,"type":104,"citation":116},"20970888","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\u002Fj.annemergmed.2010.09.010.",{"pmid":118,"type":104,"citation":119},"21773855","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\u002Fs12630-011-9560-0. Epub 2011 Jul 20.",{"pmid":121,"type":104,"citation":122},"23432384","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\u002Fbcp.12094.",{"pmid":124,"type":104,"citation":125},"25060254","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\u002Fj.emc.2014.04.011. Epub 2014 Jun 7.",{"pmid":127,"type":104,"citation":128},"25203083","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\u002Fjama.2014.10517.",{"pmid":130,"type":104,"citation":131},"16508405","Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097\u002F00000542-200603000-00025.",{"pmid":133,"type":104,"citation":134},"26758915","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\u002Fblood-2015-09-618538. Epub 2016 Jan 12.",{"pmid":136,"type":104,"citation":137},"24052549","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\u002Fblood-2013-05-498311. Epub 2013 Sep 19.",[],{"nct_id":4,"conditions":140,"biomarkers":143},[141,142],"Sickle Cell Disease","Vaso-occlusive pain episode in sickle cell disease",[],{"nct_id":4,"found":145,"summary":146,"prompt_version":156},true,{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This interventional study plans to enroll 400 participants. It compares the use of low-dose Ketamine to standard opioid care.","completed","Low-Dose Ketamine for Sickle Cell Pain Crisis","This study is looking at whether low-dose Ketamine works better than opioids (like Morphine or Dilaudid) for treating pain during a sickle cell crisis. Researchers want to see if Ketamine can reduce the number of times patients need to be admitted to the hospital for pain control. They also want to know if Ketamine helps patients get pain relief faster. You might be able to join if you are 2 to 21 years old, have sickle cell disease, and come to the emergency department with a pain crisis. You cannot join if you have a Ketamine allergy, are pregnant, or have certain other health conditions. The study will compare patients who receive Ketamine to those who received standard opioid care in the past.","The study will track hospital admission rates for 36 months after enrollment.",123,"If you participate, you would receive Ketamine within 30 minutes of arriving at the emergency department, and potentially two more doses an hour apart. Vitals and pain levels will be checked frequently.","Not stated in the trial record.",[],"v2"]