Rectal Indomethacin vs Intravenous Ketorolac

Phase 4RecruitingNCT05664074

David Vitale MD192 enrolled

Overview

Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

192

Conditions

Post-ERCP Acute Pancreatitis

Interventions

Rectal indomethacinDRUG

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

IV ketorolacDRUG

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla) * Age 6 month- 21 years old * Does not meet exclusion criteria Exclusion Criteria: * \< 10 kg * Low risk subgroup: Biliary indication with history of prior biliary sphincterotomy. * High risk for bleeding (Example: Planned liver biopsy) * Gastrointestinal bleeding in previous 3 days * Acute pancreatitis (within 3 days) at the time of ERCP * Use of NSAIDs in the previous 5 days * Peptic ulcer disease * Acute kidney Injury or Known Chronic Kidney Disease per KDIGO * Pregnancy (Pregnancy tests are administered prior to ERCP as standard of care) * Lithium therapy * Allergy to ketorolac or indomethacin * Organ Dysfunction or SIRS

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Post-ERCP Pancreatitis

Number of patient who develop Post-ERCP Pancreatitis- Post ERCP Pancreatitis: A patient must have at least 2 of the following to establish a diagnosis of post ERCP pancreatitis: 1. Characteristic physical exam findings- pain worse than admission per pain scales (please see point 2) and/or nausea 2. Amylase (unit/L) or lipase(unit/L) greater than 3 times the age appropriate upper limit of normal. * Normal range of amylase (15-127 unit/L) * Normal range of lipase (12-50 unit/L) 3. Confirmatory imaging (Ultrasound, CT or MRI) that suggests or demonstrates pancreatic inflammation

Time frame: 2 weeks

Secondary Outcomes

Pain assessed by FLACC or NRS scoring post ERCP

A minimum of 3 pain assessments are to be completed by nursing staff/anesthesia during admission: Anesthesia/ PACU- initial pain assessment Evening-2100- pain assessment by RN Morning -0800- pain assessment by RN Face, Legs, Activity, Cry, and Consolability (FLACC) Pain scale for patients 0-5 years of age and patients unable to verbalize pain Numeric Rating Scale (NRS) Pain scale for patients 6 years old and above 1. Mild- 0 to 3 2. Moderate- 4 to 6 3. Severe- 7 to 10

Time frame: 2 weeks

Laboratory markers associated PEP (Amylase and Lipase)

Amylase (unit/L) Lipase (unit/L)

Time frame: 2 weeks

Length of stay

Time frame: 2 weeks

Severity of pancreatitis (mild, moderately severe, severe)

Severity of Acute Pancreatitis (AP): Severity of AP will be classified as mild, moderately severe, or severe in accordance with the NASPGHAN Classification system. 1. Mild: "AP that is not associated with any organ failure, local or systemic complications, and usually resolves within the first week after presentation." 2. Moderately Severe: "AP with either the development of transient organ failure/dysfunction (lasting no \>48 hours) or development of local or systemic complications. Local complications would include development of (peri) or pancreatic complications including fluid collections or necrosis. Systemic complications would include exacerbation of previously diagnosed co-morbid disease (such as lung disease or kidney disease)." 3. Severe: "AP with development of organ dysfunction per International pediatric sepsis consensus conference that persists \>48 hours. Persistent organ failure may be single or multiple, and may develop beyond the first 48 hours of presentation."

Central Contacts

Tyler Thompson, BS

CONTACT

513-517-1055 tyler.thompson@cchmc.org

Ethan Estes

CONTACT

513-803-4322 James.Estes@cchmc.org

Data from ClinicalTrials.gov

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