Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
| العنوان: | Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease |
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| المؤلفون: | Haitham M. Abdelwahab, Talal M. Almutairi, Abdullah A. Al Mulhim, Mohammed Alshahrani, Bader K. Alossaimi, Donia Alfaraj, Mohamed M. Moussa, Omaima F. ElSayed, Waleed Alhazzani, Samar AlKenany, Alaa M. Mahmoud, Amal H. Al Sulaibikh, Samar A. Al Nahhash, Duaa A. AlSulaiman, Laila Perlas Asonto, Sukayna Z. Al Faraj, Mohamed M. El Tahan, Faisal M. Al Hawaj, Murad F. Al Abbad, Mohammed A Al Jumaan, Saad D. Al Shahrani, Thamir O. Al Junaid, Shaikah K. Alotaibi, Moath N. Aldarweesh, Nisreen Almaghraby |
| المصدر: | Trials, Vol 20, Iss 1, Pp 1-7 (2019) Trials |
| بيانات النشر: | BMC, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Randomized control trial, Anemia, Medicine (miscellaneous), Anemia, Sickle Cell, Disease, law.invention, Study Protocol, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Outcome Assessment, Health Care, medicine, Humans, Pharmacology (medical), Ketamine, Prospective Studies, 030212 general & internal medicine, Acute painful crisis, Randomized Controlled Trials as Topic, Pain score, lcsh:R5-920, Morphine, business.industry, Sickle cell disease, medicine.disease, Acute Pain, Opioid, Research Design, Anesthesia, business, lcsh:Medicine (General), 030217 neurology & neurosurgery, Treatment Arm, medicine.drug |
| الوصف: | Background Sickle cell disease (SCD) is an inherited hematological disorder where the shape of red blood cells is altered, resulting in the destruction of red blood cells, anemia, and other complications. SCD is prevalent in the southern and eastern provinces of the Arabian peninsula. The most common complications for individuals with SCD are acute painful episodes that require several doses of intravenous opioids, making pain control for these individuals challenging. Instead of opioids, some studies have suggested that ketamine might be used for pain control in acute pain episodes of individuals with SCD. This study aims to evaluate whether the addition of ketamine to morphine can achieve better pain control, decreasing the number of repeated doses of opiates. We hypothesize that early administration of ketamine would lead to a more rapid improvement in pain score and lower opioid requirements. Methods and analysis This study will be a prospective, randomized, concealed, blinded, pragmatic parallel group, controlled trial enrolling adult patients with SCD and acute vaso-occlusive crisis pain. All patients will receive standard analgesic therapy during evaluation. Patients randomized to the treatment arm will receive low-dose ketamine (0.3 mg/kg in 0.9% sodium chloride, 100 ml bag) in addition to standard intravenous hydration, while those in the control group will receive a standard dose of morphine (0.1 mg/kg in 0.9% sodium chloride, 100 ml bag) in addition to the standard intravenous hydration. All healthcare providers will be blinded to the treatment arm. Data will be analyzed according to the intention-to-treat principle. The primary outcome is improvement in pain severity using the Numerical Pain Rating Score. Trial registration Clinicaltrials.gov, NCT03431285. Registered on 13 February 2018 Electronic supplementary material The online version of this article (10.1186/s13063-019-3394-4) contains supplementary material, which is available to authorized users. |
| اللغة: | English |
| تدمد: | 1745-6215 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::193c5214091d3ad5815d1639fe45a09c http://link.springer.com/article/10.1186/s13063-019-3394-4 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....193c5214091d3ad5815d1639fe45a09c |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 17456215 |
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