Abstract
BackgroundSickle 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 analysisThis 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 registrationClinicaltrials.gov, NCT03431285. Registered on 13 February 2018
Highlights
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
Sickle cell disease (SCD) is an inherited hematological disorder where the shape of red blood cells is altered into sickle-like cells resulting in the destruction of red blood cells leading to anemia and other hematological complications
Primary hypothesis We hypothesize that early administration of ketamine in combination with standard acute opiate treatment will achieve a more rapid reduction in pain score defined as an improvement in the Numerical Pain Rating Score (NPRS) of 1.5 points or more compared with the control arm for pain relief in SCD patients with vaso-occlusive crises (VOCs) pain
Summary
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. An extensive search of the literature revealed few reports on low-dose ketamine in the management of acute painful crises in SCD patients The results of these reports were limited by their retrospective designs and the inclusion of relatively small sample sizes [11–13]. A recent Canadian retrospective study adding intravenous ketamine in the management of nine patients with painful sickle cell crisis showed significant reductions in cumulative morphine consumption (146 ± 16.5 mg/day versus 112 ± 12.2 mg/day) and pain scores [14]. To the best of our knowledge, there are no previously published large, prospective, randomized controlled trials investigating the impact of adding low-dose ketamine on improving the quality of analgesia in patients with VOC in SCD patients
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