Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis

Официальное название

Evaluation of a Standardized Low-Dose Bolus Ketamine Pathway for Management of Pediatric Sickle Cell Patients Presenting to the Emergency Department With Pain

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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/kg/dose.
• Другое Standard Care (in control arm)
  Standard Care in Historical Control Group

Первичные конечные точки

• Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids. [Срок оценки: From time of patient enrollment and IRB approval for 36 months]

Вторичные конечные точки (5)

• Emergency Department length of stay after using the Ketamine first pathway. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From time of patient enrollment and IRB approval until 36 months]
• Adverse events experienced after using a Ketamine first pathway [Срок оценки: From time of patient enrollment and IRB approval until 36 months.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Mississippi Medical Center, Pediatric Emergency Department — Jackson

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07682662 · UMMC-IRB-2026-154

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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