Status:
TERMINATED
Initial Pain Management in Pediatric Pancreatitis: Opioid vs. Non-Opioid
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
The National Pancreas Foundation
Conditions:
Acute Pancreatitis
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
This will be a phase 2, single-center, unblinded randomized controlled pilot trial of two arms comparing opioid-sparing analgesia to the current Boston Children's Hospital institutional practice which...
Detailed Description
Acute pancreatitis (AP) is the most common pancreatic disease of childhood with an increasing incidence estimated at 13.2 cases in 100,000 children per year. Given the dearth of pediatric literature, ...
Eligibility Criteria
Inclusion
- 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
- 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 who received intravenous opioid patient-controlled analgesia (PCA) in transit or during their ED admission.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04291599
Start Date
March 15 2022
End Date
July 24 2025
Last Update
January 8 2026
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115