Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
Mohammed S. Alshahrani,
Laila Perlas Asonto,
Mohamed M. El Tahan,
Amal H. Al Sulaibikh,
Sukayna Z. Al Faraj,
Abdullah A. Al Mulhim,
Murad F. Al Abbad,
Samar A. Al Nahhash,
Moath N. Aldarweesh,
Alaa M. Mahmoud,
Nisreen Almaghraby,
Mohammed A. Al Jumaan,
Thamir O. Al Junaid,
Faisal M. Al Hawaj,
Samar AlKenany,
Omaima F. ElSayed,
Haitham M. Abdelwahab,
Mohamed M. Moussa,
Bader K. Alossaimi,
Shaikah K. Alotaibi,
Talal M. AlMutairi,
Duaa A. AlSulaiman,
Saad D. Al Shahrani,
Donia Alfaraj,
Waleed Alhazzani
Affiliations
Mohammed S. Alshahrani
Emergency and Critical Care Departments, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Laila Perlas Asonto
Emergency and Critical Care Departments, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Mohamed M. El Tahan
Anesthesia Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam, Kingdom of Saudi Arabia, Mansoura University
Amal H. Al Sulaibikh
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Sukayna Z. Al Faraj
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Abdullah A. Al Mulhim
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Murad F. Al Abbad
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Samar A. Al Nahhash
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Moath N. Aldarweesh
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Alaa M. Mahmoud
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Nisreen Almaghraby
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Mohammed A. Al Jumaan
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Thamir O. Al Junaid
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Faisal M. Al Hawaj
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Samar AlKenany
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Omaima F. ElSayed
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Haitham M. Abdelwahab
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Mohamed M. Moussa
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Bader K. Alossaimi
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Shaikah K. Alotaibi
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Talal M. AlMutairi
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Duaa A. AlSulaiman
Pharmacy Department, King Fahad Hospital of the University
Saad D. Al Shahrani
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Donia Alfaraj
Emergency Department, King Fahad Hospital of the University, Imam Abdulrahman bin Faisal University-Dammam
Waleed Alhazzani
Department of Clinical Epidemiology and Biostatistics, McMaster University
Abstract 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
