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Indomethacin vs Ketorolac for Pancreatitis

Phase 4

Recruiting

Led By David Vitale, MD

Research Sponsored by David Vitale MD

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 2 weeks

Awards & highlights

Study Summary

This trial compares the effectiveness of two medications to reduce rates of post-ERCP pancreatitis in children who are having an ERCP.

Who is the study for?

This trial is for children and young adults aged 6 months to 21 years who are scheduled for an ERCP procedure. Participants must not have kidney disease, be pregnant, weigh less than 10 kg, or have a high bleeding risk. They should not have taken NSAIDs recently or have acute pancreatitis at the time of ERCP.Check my eligibility

What is being tested?

The study compares rectal indomethacin with IV ketorolac in preventing post-ERCP pancreatitis in pediatric patients. It's the first study of its kind in this age group and aims to determine which medication is more effective at reducing PEP rates after the procedure.See study design

What are the potential side effects?

Possible side effects include allergic reactions to either drug, gastrointestinal issues like ulcers due to their nature as NSAIDs, potential bleeding complications especially if there's a history of peptic ulcer disease or recent GI bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-ERCP Pancreatitis

Secondary outcome measures

C-Reactive Protein (CRP) level

Hematocrit

Hemoglobin

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Rectal indomethacinExperimental Treatment1 Intervention

Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg

Group II: IV ketorolacExperimental Treatment1 Intervention

Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IV ketorolac

2023

Completed Phase 4

~380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

David Vitale MDLead Sponsor

1 Previous Clinical Trials

60 Total Patients Enrolled

David VitaleLead Sponsor

David Vitale, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Rectal indomethacin Clinical Trial Eligibility Overview. Trial Name: NCT05664074 — Phase 4

Acute Pancreatitis Research Study Groups: Rectal indomethacin, IV ketorolac

Acute Pancreatitis Clinical Trial 2023: Rectal indomethacin Highlights & Side Effects. Trial Name: NCT05664074 — Phase 4

Rectal indomethacin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664074 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you elucidate the potential hazard of Rectal indomethacin to patients?

"Rectal indomethacin has been approved for use, thereby receiving a score of 3 on the safety scale."

Answered by AI

Does this study have an age restriction, including participants who are 18 or older?

"This clinical trial is suitable for patients aged between 6 months and 21 years. There are 9 studies dedicated to minors, while 77 trials focus on those over 65."

Answered by AI

Are there opportunities still accessible to participate in this clinical experiment?

"Affirmatively, the study is currently recruiting. Clinicaltrials.gov displays that this trial was posted in November of 2022 and most recently updated on December 21st . 192 participants are necessary for completion from a single medical facility."

Answered by AI

What is the cap for enrolment in this clinical research?

"Affirmative. The information available from clinicaltrials.gov confirms that this study is currently searching for participants. It was initially posted on November 7th 2022 and has undergone a recent update as of December 21st 2022. A total 192 patients will be recruited at one site only."

Answered by AI

What criteria must one meet to be eligible for this clinical trial?

"This medical research is looking for 192 patients with post-ERCP acute pancreatitis in the age range of 6 months to 21 years old. Primary requirements are that they have undergone ERCP (diagnostic or therapeutic) and do not qualify as exceptions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rectal Indomethacin vs Intravenous Ketorolac

David Vitale MD 2022. "Rectal Indomethacin vs Intravenous Ketorolac". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05664074.

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