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Non-Opioid Analgesic

Non-Opioid vs. Opioid Pain Management for Pediatric Pancreatitis (PATIENCE Trial)

Phase 2
Recruiting
Led By Amit Grover, MB BCh BAO
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of trial, approximately 1 year from the start of enrollment
Awards & highlights

Summary

This trial will compare two methods of pain relief for kids with pancreatitis in the emergency room. One group will get the usual care, which often includes opioids, and the other group will get an opioid-sparing method. The trial will help researchers understand how well the new method works and how to design a bigger, better trial.

Who is the study for?
This trial is for children and young adults up to 21 years old who weigh at least 8 kg and are admitted to Boston Children's Hospital with acute pancreatitis or an acute episode of chronic pancreatitis. It excludes those with bleeding disorders, pregnant females, ICU patients, transfers from other hospitals, allergies to morphine or NSAIDs, prior opioid PCA use in transit/ED admission, peptic ulcer history, renal/hepatic insufficiency, or substance abuse.
What is being tested?
The study compares two pain management strategies for pediatric pancreatitis: one group receives Ketorolac (a non-opioid), while the other gets standard opioids. This phase 2 pilot trial aims to measure effects for a future larger-scale study. Participants are randomly assigned to either treatment without blinding.
What are the potential side effects?
Ketorolac may cause gastrointestinal issues like ulcers and bleeding; kidney problems; allergic reactions; and increased risk of heart attack or stroke. Opioids can lead to constipation, nausea/vomiting, drowsiness, respiratory depression (slow breathing), dependency/addiction issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of trial, approximately 1 year from the start of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of trial, approximately 1 year from the start of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Analgesics, Opioid
Secondary study objectives
Length of stay
Pain resolution: pain scores
Predefined Feasibility Outcomes to Assess Trial Success
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm - Ketorolac (Opioid-Sparing)Experimental Treatment1 Intervention
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.
Group II: Control Arm - Conventional Treatment/Standard of Hospital CareActive Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
2014
Completed Phase 4
~1760

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
778 Previous Clinical Trials
5,580,962 Total Patients Enrolled
The National Pancreas FoundationOTHER
4 Previous Clinical Trials
627 Total Patients Enrolled
Amit Grover, MB BCh BAOPrincipal InvestigatorBoston Children's Hospital

Media Library

Ketorolac (Non-Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04291599 — Phase 2
Acute Pancreatitis Research Study Groups: Experimental Arm - Ketorolac (Opioid-Sparing), Control Arm - Conventional Treatment/Standard of Hospital Care
Acute Pancreatitis Clinical Trial 2023: Ketorolac Highlights & Side Effects. Trial Name: NCT04291599 — Phase 2
Ketorolac (Non-Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04291599 — Phase 2
~14 spots leftby Sep 2025
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