Back to resultsRectal Indomethacin vs Intravenous Ketorolac
Primary Purpose
Post-ERCP Acute Pancreatitis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rectal indomethacin
IV ketorolac
Sponsored by
About this trial
This is an interventional prevention trial for Post-ERCP Acute Pancreatitis
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Rectal indomethacin
IV ketorolac
Arm Description
Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Laboratory markers associated PEP (Amylase and Lipase)
Amylase (unit/L) Lipase (unit/L)
Length of stay
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."
C-Reactive Protein (CRP) level
Measured in mg/dL
Post-ERCP bleeding
White Blood Cell
per/mcL
Red Blood Cell
per/mcL
Hemoglobin
gm/dL
Hematocrit
MCV
fL
MCH
pg
MCHC
gm/dL
RDW
PLATELET
per/mcL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05664074
Brief Title
Rectal Indomethacin vs Intravenous Ketorolac
Official Title
Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Vitale
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This will be a prospective study where patients will be randomized into either rectal indomethacin or IV ketorolac.
Masking
Participant
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rectal indomethacin
Arm Type
Experimental
Arm Description
Dosage based on subject's weight:
>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
Arm Title
IV ketorolac
Arm Type
Experimental
Arm Description
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
Intervention Type
Drug
Intervention Name(s)
Rectal indomethacin
Intervention Description
Dosage based on subject's weight:
>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
Intervention Type
Drug
Intervention Name(s)
IV ketorolac
Intervention Description
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
Primary Outcome Measure Information:
Title
Post-ERCP Pancreatitis
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Pain assessed by FLACC or NRS scoring post ERCP
Description
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
Time Frame
2 weeks
Title
Laboratory markers associated PEP (Amylase and Lipase)
Description
Amylase (unit/L) Lipase (unit/L)
Time Frame
2 weeks
Title
Length of stay
Time Frame
2 weeks
Title
Severity of pancreatitis (mild, moderately severe, severe)
Description
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."
Time Frame
2 weeks
Title
C-Reactive Protein (CRP) level
Description
Measured in mg/dL
Time Frame
2 weeks
Title
Post-ERCP bleeding
Time Frame
2 weeks
Title
White Blood Cell
Description
per/mcL
Time Frame
2 weeks
Title
Red Blood Cell
Description
per/mcL
Time Frame
2 weeks
Title
Hemoglobin
Description
gm/dL
Time Frame
2 weeks
Title
Hematocrit
Time Frame
2 weeks
Title
MCV
Description
fL
Time Frame
2 weeks
Title
MCH
Description
pg
Time Frame
2 weeks
Title
MCHC
Description
gm/dL
Time Frame
2 weeks
Title
RDW
Time Frame
2 weeks
Title
PLATELET
Description
per/mcL
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tyler Thompson, BS
Phone
513-517-1055
Email
tyler.thompson@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ethan Estes
Phone
513-803-4322
Email
James.Estes@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Vitale, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Rectal Indomethacin vs Intravenous Ketorolac
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