Initial Pain Management in Pediatric Pancreatitis: Opioid vs. Non-Opioid (PATIENCE)
Acute Pancreatitis
About this trial
This is an interventional supportive care trial for Acute Pancreatitis focused on measuring Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Patients who present to the ED and are admitted to BCH with a diagnosis of acute pancreatitis or an acute bout of chronic pancreatitis based on INSPPIRE14 Criteria (Appendix 1)
- Age ≤21 years
- Patient weight ≥8 kg
Exclusion Criteria:
- Allergy to morphine (and hydromorphone) or aspirin/NSAID
- History of renal or hepatic insufficiency
- History of peptic ulceration
- History of bleeding diathesis
- Pregnant females
- Patients who have a documented history of substance abuse disorder or those who use opioids chronically
- Patients admitted to the Intensive Care Unit (ICU)
- Patients admitted via transfer to BCH from another hospital (ED or inpatient)
- Patients who received intravenous opioid patient-controlled analgesia (PCA) in transit or during their ED admission.
Sites / Locations
- Boston Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental Arm - Ketorolac (Opioid-Sparing)
Control Arm - Conventional Treatment/Standard of Hospital Care
Patients assigned to this arm of the study will follow the standardized step-up approach to pain management per the hospital Evidenced Based Guideline (EBG). If analgesia is not obtained with first-line medications such as acetaminophen, the patient will be given the NSAID ketorolac intravenously every 6 hours at the standard weight-based dose throughout hospitalization. If the patient experiences continued pain, they (or their guardian/ caregiver) may request a rescue medication in the form of low-dose morphine (or an alternative opioid if allergic to morphine) at 0.025 mg/kg/dose every 4 hours.
Patients assigned to this arm of the study will be treated per institutional policy and procedural care as dictated by established hospital order sets and at the discretion of the provider. This may involve the step-up approach per the hospital EBG utilizing acetaminophen or ibuprofen as first-line agents; however, it remains at the discretion of the treating provider. The current standard of care for children presenting to the ED is based on prescribing order sets within the electronic medical record (EMR). Physicians in the BCH emergency department choose in an intermittently-prescribed manner, standard doses of analgesia including acetaminophen (Tylenol) or ibuprofen per the hospital EBG, as well as opioids (morphine, hydromorphone).