Initial Pain Management in Pediatric Pancreatitis: Opioid vs. Non-Opioid

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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 has been reported to predominantly include administration of opioids as a first-line analgesic to pediatric patients who present to the emergency department with a diagnosis of acute pancreatitis (AP). This is a pilot trial for which many outcomes have not previously been studied in the pediatric AP population. The focus of this investigation will be to investigate the magnitude and variability of effect sizes for designing a future multi-center, double-blinded randomized controlled trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborator: The National Pancreas Foundation
• Treatments: Analgesics, Non-Narcotic; Analgesics, Opioid; Hydromorphone; Ketorolac; Ketorolac Tromethamine; Morphine

Criteria

Inclusion Criteria:

1. 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)

2. Age ≤21 years

3. Patient weight ≥8 kg

Exclusion Criteria:

1. Allergy to morphine (and hydromorphone) or aspirin/NSAID

2. History of renal or hepatic insufficiency

3. History of peptic ulceration

4. History of bleeding diathesis

5. Pregnant females

6. Patients who have a documented history of substance abuse disorder or those who use opioids chronically

7. Patients admitted to the Intensive Care Unit (ICU)

8. Patients admitted via transfer to BCH from another hospital (ED or inpatient)

9. Patients who received intravenous opioid patient-controlled analgesia (PCA) in transit or during their ED admission.