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

Who is this study for? Patients with Acute Pancreatitis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Amit Grover, MB BCh BAO
Amit.Grover@childrens.harvard.edu
617-355-6058
Backup
Shannon Manzi, PharmD
Shannon.Manzi@childrens.harvard.edu
617-355-2837
Time Frame
Start Date: 2022-03-15
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 50
Treatments
Experimental: Experimental Arm - Ketorolac (Opioid-Sparing)
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.
Active_comparator: Control Arm - Conventional Treatment/Standard of Hospital Care
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).
Sponsors
Collaborators: The National Pancreas Foundation
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov