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

NCT04291599 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ketorolac

Subjects will be randomized to either receive opioid (standard of care) or opioid-sparing analgesia.

DRUG

Opioid

Subjects will be randomized to either receive opioid (standard of care) or opioid-sparing analgesia

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2025-07-24
Completion
2025-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291599 on ClinicalTrials.gov