Comparing opioid and non-opioid pain management in children with pancreatitis
Initial Pain Management in Pediatric Pancreatitis: Opioid vs. Non-Opioid
This study is testing if using non-opioid pain relief works just as well as opioids for kids with pancreatitis to help them feel better and reduce side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04291599 on ClinicalTrials.gov |
What this trial studies
This phase 2 pilot trial aims to compare opioid-sparing analgesia with the current practice of opioid administration for pediatric patients diagnosed with acute pancreatitis at Boston Children's Hospital. The study will involve a randomized controlled design to assess the effectiveness and variability of pain management strategies in this population. Given the lack of pediatric-specific guidelines, this trial seeks to gather data that could inform future multi-center studies and improve pain management protocols for children. The focus is on understanding the outcomes related to pain relief and side effects associated with both treatment approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 21 years or younger who are admitted to the emergency department with a diagnosis of acute pancreatitis.
Not a fit: Patients with a history of substance abuse disorder, those who are pregnant, or those with certain medical conditions such as renal or hepatic insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective pain management strategies for children suffering from acute pancreatitis.
How similar studies have performed: While there is limited pediatric literature on this topic, the study addresses a significant gap in knowledge regarding pain management in pediatric acute pancreatitis, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 who received intravenous opioid patient-controlled analgesia (PCA) in transit or during their ED admission.
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Amit Grover, MB BCh BAO — Boston Children's Hospital
- Study coordinator: Amit Grover, MB BCh BAO
- Email: Amit.Grover@childrens.harvard.edu
- Phone: 617-355-6058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.