2.1. Study design
nausea or, pain, vomits, abdominal pain
ACUTE PANCREATITIS
This will be a multicenter open-label pilot randomized controlled clinical trial to assess the safety, efficacy, and non-inferiority of home monitoring compared to in-hospital care for mild AP. Patients will be randomly assigned (1:1) to either the home monitoring (experimental) group or the in-hospital (control) group (see Fig. Study Flowchart. ER = emergency room. *Patients requiring admission periods longer than 72 hours will be visited in the outpatient clinic 5–7 days after discharge.All patients with abdominal pain and clinical suspicion of acute pancreatitis will be initially evaluated by each center’s emergency room (ER) specialist physician. Once the diagnosis of mild AP is confirmed (Time 0), we will follow the 2012 Revised Atlanta Classification CriteriaSupportive care in the ER at Time 0 will consist of intravenous administration of fluid therapy, analgesia with acetaminophen 1 g/8 h interchanged with dipyrone 575 mg/8 h (or Dexketoprofen 25 mg/8 h, if allergies/intolerance); antiemetic treatment with Ondansetron 4 mg/8 h; gastroprotective treatment with Omeprazole 20 mg/24 h. After 12 hours in the ER (Time 1), patients will be reassessed for severity and, if adequate pain control (Visual Analogue Scale [VAS] ≤ 3) and no nausea or vomits, we will assess oral feeding tolerance.After 15 hours and before 24 hours after Time 0 (Time 2), patients still presenting VAS ≤ 3 and adequate oral feeding tolerance will be fully informed about the study, provided with the information sheet and invited to participate. If they accept, we will ask them to sign the written informed consent. Afterward, we will perform the randomization, and patients will be informed of their assigned study group.