TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-15
Study Completion:2025-07-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04291599

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.

Ages Eligible for Study:Not specified to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Age ≤21 years
  3. 3. Patient weight ≥8 kg
  1. 1. Allergy to morphine (and hydromorphone) or aspirin/NSAID
  2. 2. History of renal or hepatic insufficiency
  3. 3. History of peptic ulceration
  4. 4. History of bleeding diathesis
  5. 5. Pregnant females
  6. 6. Patients who have a documented history of substance abuse disorder or those who use opioids chronically
  7. 7. Patients admitted to the Intensive Care Unit (ICU)
  8. 8. Patients who received intravenous opioid patient-controlled analgesia (PCA) in transit or during their ED admission.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-15
Study Completion Date2025-07-24

Study Record Updates

Study Start Date2022-03-15
Study Completion Date2025-07-24

Terms related to this study

Keywords Provided by Researchers

  • Pancreatitis

Additional Relevant MeSH Terms

  • Acute Pancreatitis