Rectal Indomethacin vs Intravenous Ketorolac

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664074
• Other study ID #: 2022-0640
• Status: Recruiting
• Phase: Phase 4
• Start date: November 7, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Tyler Thompson, BS
• Phone: 513-517-1055
• Email: tyler.thompson[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Drug:
• Rectal indomethacin
Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
• IV ketorolac
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
David Vitale MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Characteristic physical exam findings- pain worse than admission per pain scales (please see point 2) and/or nausea; 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); Confirmatory imaging (Ultrasound, CT or MRI) that suggests or demonstrates pancreatic inflammation	2 weeks
Secondary	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; Mild- 0 to 3; Moderate- 4 to 6; Severe- 7 to 10	2 weeks
Secondary	Laboratory markers associated PEP (Amylase and Lipase)	Amylase (unit/L) Lipase (unit/L)	2 weeks
Secondary	Length of stay		2 weeks
Secondary	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.; Mild: "AP that is not associated with any organ failure, local or systemic complications, and usually resolves within the first week after presentation."; 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)."; 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."	2 weeks
Secondary	C-Reactive Protein (CRP) level	Measured in mg/dL	2 weeks
Secondary	Post-ERCP bleeding		2 weeks
Secondary	White Blood Cell	per/mcL	2 weeks
Secondary	Red Blood Cell	per/mcL	2 weeks
Secondary	Hemoglobin	gm/dL	2 weeks
Secondary	Hematocrit		2 weeks
Secondary	MCV	fL	2 weeks
Secondary	MCH	pg	2 weeks
Secondary	MCHC	gm/dL	2 weeks
Secondary	RDW		2 weeks
Secondary	PLATELET	per/mcL	2 weeks