Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Официальное название

Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients

Обзор

The proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular ICU. We intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.

Подробное описание

The mainstay of postoperative pain control in the CVICU remains opiate-based therapy. Reliance on this class of medications can be detrimental, contributing to complications including hemodynamic instability, dependency, and withdrawal which can ultimately lead to longer hospital admissions, as well as long term and persistent neurodevelopmental effects. In addition, the opioid crisis has driven practitioners to aim for methods to reduce opioid exposure and post-operative narcotic prescriptions in pediatric and adult patients alike. There is a growing body of evidence in the adult literature showing promising results with the use of a continuous infusion of ketorolac in postoperative patients, including in a pediatric population. What the current literature has failed to show is whether a continuous infusion of ketorolac post operatively decreases the use of opiate mediations in a pediatric population compared to intermittent bolus injections, which is the current standard of care. Given the sensitivity and fragility inherent in those patients with CHD, working to reduce deleterious effects from excessive and prolonged opiate exposure is imperative. This study aims to examine whether the use of a continuous infusion of ketorolac can reduce the amount of opiates needed to treat postoperative pain control in the pediatric CVICU population, in comparison to patients who receive intermittent ketorolac within the first 72 hours post-operatively.

Вмешательства

• Препарат Continuous ketorolac
  Patients randomized for the treatment arm of the study group will receive a continuous infusion of ketorolac plus an intermittent dose of placebo (plasmalyte) for 48 hours.

Первичные конечные точки

• 1. Total fentanyl dose equivalents received within the first 96 hours post-operatively [Срок оценки: Within 72 hours of cardiac surgery]

Вторичные конечные точки (5)

• 1. Total fentanyl equivalents received in each 24 hour period before and after initiating the study drug [Срок оценки: Within 72 hours after cardiac surgery]
• Rate of acute kidney injury measured by pRIFLE criteria [Срок оценки: Within 72 hours after cardiac surgery]
• Major bleeding events [Срок оценки: Within 72 hours after cardiac surgery]
• Pain scores [Срок оценки: Within 72 hours after cardiac surgery]
• Sedative agent requirements [Срок оценки: Within 72 hours after cardiac surgery]

Критерии участия

Критерии включения

• All patients aged 3 months to 4 years 11months admitted post operatively to the CVICU during the time period in which the study will be ongoing
• Initiation of study medication within the first 12-24 hours post-operatively
• The cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive Ketorolac for pain control

Критерии исключения

• Patients that have acute kidney injury, as defined by the letter "I" in the pRIFLE criteria.
• History of allergy or sensitivity reaction to ketorolac or any NSAID medications.
• Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively
• Orthotopic heart transplantation
• Clinically significant bleeding
• Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Phoenix Children's Hospital — Phoenix

Публикации

• Onaka T, Yagi K. Differential effects of naloxone on neuroendocrine responses to fear-related emotional stress. Exp Brain Res. 1990;81(1):53-8. doi: 10.1007/BF00230100. PMID 2168320
• Burd RS, Tobias JD. Ketorolac for pain management after abdominal surgical procedures in infants. South Med J. 2002 Mar;95(3):331-3. PMID 11902701
• Burns JW, Aitken HA, Bullingham RE, McArdle CS, Kenny GN. Double-blind comparison of the morphine sparing effect of continuous and intermittent i.m. administration of ketorolac. Br J Anaesth. 1991 Sep;67(3):235-8. doi: 10.1093/bja/67.3.235. PMID 1911008
• Cohen MN, Christians U, Henthorn T, Vu Tran Z, Moll V, Zuk J, Galinkin J. Pharmacokinetics of single-dose intravenous ketorolac in infants aged 2-11 months. Anesth Analg. 2011 Mar;112(3):655-60. doi: 10.1213/ANE.0b013e3182075d04. Epub 2011 Jan 13. PMID 21233498
• Dawkins TN, Barclay CA, Gardiner RL, Krawczeski CD. Safety of intravenous use of ketorolac in infants following cardiothoracic surgery. Cardiol Young. 2009 Feb;19(1):105-8. doi: 10.1017/S1047951109003527. Epub 2009 Jan 12. PMID 19134246
• Grimsby GM, Conley SP, Trentman TL, Castle EP, Andrews PE, Mihalik LA, Hentz JG, Humphreys MR. A double-blind randomized controlled trial of continuous intravenous Ketorolac vs placebo for adjuvant pain control after renal surgery. Mayo Clin Proc. 2012 Nov;87(11):1089-97. doi: 10.1016/j.mayocp.2012.07.018. Epub 2012 Oct 8. PMID 23058854
• Gupta A, Daggett C, Drant S, Rivero N, Lewis A. Prospective randomized trial of ketorolac after congenital heart surgery. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):454-7. doi: 10.1053/j.jvca.2004.05.024. PMID 15365927
• Howard ML, Isaacs AN, Nisly SA. Continuous Infusion Nonsteroidal Anti-Inflammatory Drugs for Perioperative Pain Management. J Pharm Pract. 2018 Feb;31(1):66-81. doi: 10.1177/0897190016665539. Epub 2016 Aug 31. PMID 27580638

Идентификаторы

NCT: NCT04040452 · 166166

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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