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

Description

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.

Conditions

Acute Pancreatitis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Amit Grover, MB BCh BAO, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

2024-06-30