Objectives: To compare the analgesic effects of intravenous (IV) ketamine with IV morphine sulfate in acute lower limb trauma.
Design: This is a single center, phase 1, randomized double blinded clinical trial performed on 60 patients presenting with acute limb trauma to the Emergency Department (ED). Patients are consecutively assigned to 2 groups to receive ketamine or morphine for analgesia by block randomization method. Blinding is performed by assigning numbers to syringes. The researcher, nurse, and patient are unaware of drug administered in the study period.
Setting and conduct: This study is performed in Bahonar Academic Hospital in Kerman, Iran. Data collection and monitoring are performed by a resident of Emergency Medicine (EM) and an attending physician of EM, respectively.
Participants: Patients over 18 years of age with acute lower limb trauma are included in the study. Patients with hypersensitivity to ketamine or morphine, unstable hemodynamic signs, altered mental status, signs of increased Intra-cerebral pressure, any distracting injuries, neuropathies, history of cardiovascular disease, and disagreement to participate will be excluded.
Interventions: Enrolled patients will be randomized into 2 groups with equal sizes (30 patients) receiving either IV ketamine or IV morphine. After signing informed consent by each patient, All patients will undergo pain intensity measurement by Numeric Rating Scale (NRS) from 0 to 10 and receive either IV ketamine (0.5mg/kg) or IV morphine (0.1mg/kg) by slow bolus administration in 5 minutes). After completion of drug administration, pain score will be re-assessed in 5, 10, and 30 minutes.
Outcomes: Pain scores at 5, 10, and 30 minutes after injection are considered as primary outcomes. Vital signs during injection and re-evaluations will be recorded and any adverse reactions to each drug will be documented.