About this trial
Introduction: This study focuses on the treatment of painful crises in Sickle Cell Disease (SCD) patients using Paracoxib, a non-opioid, compared to Morphine. It addresses the need for alternative medications that reduce opioid dependency while providing effective analgesia.
Objectives:
Primary: Evaluate the analgesic effect of Paracoxib versus Morphine in SCD vaso-occlusive crises.
Secondary: Reduce opioid use/dependence, decrease the length of hospital stays, and monitor side effects related to Paracoxib.
Methodology: A double-blinded randomized controlled trial, conducted in a tertiary care emergency department. The study includes adult SCD patients with moderate to severe crises, excluding non-VOC pain, certain medications, and specific medical conditions. The sample size is 226 patients, split equally into two groups.
Intervention: Patients receive either Morphine or Paracoxib, with periodic assessment of vital signs and pain. Additional Morphine is administered if required. Data collection and analysis are meticulously planned.
Expected Outcomes: Improvement in SCD pain management, reduction in opioid usage, and potential benefits in terms of hospital stays and patient satisfaction.
Eligibility criteria
Qualifiers
An adult (>18 years) sickle cell disease patient presents with moderate-severe vaso-occlusive crisis (VOC) to the ED.
Disqualifiers
Non-VOC Pain (e.g. Acute chest syndrome, sequestration, septic arthritis, Etc.)
Weight less than 50 KG
Recurrent visits > one visit/ week
Opioids within 24hrs
Trial design
Treatments tested in this trial
- Parecoxib
- Morphine
Treatment groups
Locations
Sponsors and collaborators
Oman Medical Speciality Board
Lead sponsor
Armed Forces Hospital, Oman
Collaborator