Rectal Indomethacin vs Intravenous Ketorolac
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rectal indomethacin Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg |
Drug: Rectal indomethacin
Dosage based on subject's weight:
>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
|
| Experimental: IV ketorolac Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) |
Drug: IV ketorolac
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
|
Outcome Measures
Primary Outcome Measures
- Post-ERCP Pancreatitis [2 weeks]
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 [2 weeks]
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) [2 weeks]
Amylase (unit/L) Lipase (unit/L)
- Length of stay [2 weeks]
- Severity of pancreatitis (mild, moderately severe, severe) [2 weeks]
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 [2 weeks]
Measured in mg/dL
- Post-ERCP bleeding [2 weeks]
- White Blood Cell [2 weeks]
per/mcL
- Red Blood Cell [2 weeks]
per/mcL
- Hemoglobin [2 weeks]
gm/dL
- Hematocrit [2 weeks]
- MCV [2 weeks]
fL
- MCH [2 weeks]
pg
- MCHC [2 weeks]
gm/dL
- RDW [2 weeks]
- PLATELET [2 weeks]
per/mcL
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- David Vitale
Investigators
- Principal Investigator: David Vitale, MD, Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
More Information
Publications
None provided.- 2022-0640