Trials · 2019
Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Alshahrani Mohammed S, Asonto Laila Perlas, El Tahan Mohamed M, Al Sulaibikh Amal H, Al Faraj Sukayna Z, Al Mulhim Abdullah A, Al Abbad Murad F, Al Nahhash Samar A, Aldarweesh Moath N, Mahmoud Alaa M, Almaghraby Nisreen, Al Jumaan Mohammed A, Al Junaid Thamir O, Al Hawaj Faisal M, AlKenany Samar, ElSayed Omaima F, Abdelwahab Haitham M, Moussa Mohamed M, Alossaimi Bader K, Alotaibi Shaikah K, AlMutairi Talal M, AlSulaiman Duaa A, Al Shahrani Saad D, Alfaraj Donia, Alhazzani Waleed
Аннотация
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.
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.