Post-ERCP Acute Pancreatitis
Conditions
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.
Interventions
Dosage based on subject's weight: \>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
DRUGIV ketorolac
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
Sponsors
David Vitale MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
This will be a prospective study where patients will be randomized into either rectal indomethacin or IV ketorolac.
Eligibility
Sex/Gender
ALL
Age
6 Months to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-ERCP Pancreatitis | 2 weeks | Below is the number of participants within the rectal indomethacin and IV ketorolac cohorts who developed 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 |
| Post-ERCP Pancreatitis: Pancreatic Duct Injections | 2 weeks | 86 participants from the rectal indomethacin cohort and 83 from IV ketorolac received pancreatic duct injections during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic duct injections. |
| Post-ERCP Pancreatitis: Native Papilla | 2 weeks | 36 participants from the rectal indomethacin cohort and 33 from IV ketorolac had a native papilla for their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who had a native papilla. |
| Post-ERCP Pancreatitis: Pancreatic Sphincterotomy | 2 weeks | 25 participants from the rectal indomethacin cohort and 19 from IV ketorolac received pancreatic sphincterotomies during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic sphincterotomies. |
| Post-ERCP Pancreatitis: Opti-Ray Amount | 2 weeks | 83 participants from the rectal indomethacin cohort and 84 from IV ketorolac received various amounts of Opti-Ray during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received Opti-Ray. |
| Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed | 2 weeks | 51 participants from the rectal indomethacin cohort and 53 from IV ketorolac received a therapeutic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received therapeutic pancreatic duct stents. |
| Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed | 2 weeks | 11 participants from the rectal indomethacin cohort and 11 from IV ketorolac received a prophylactic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received prophylactic pancreatic duct stents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU | 2 weeks | A minimum of 3 pain assessments were completed by nursing staff/anesthesia during admission: Anesthesia/ PACU- initial pain assessment Evening-2100- pain assessment by RN Morning -0800- pain assessment by RN We defined \*Pain score \> 0 (any pain) for patients in the rectal indomethacin vs. IV ketorolac cohorts using the NRS and FLACC Pain scale. 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 |
| Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening | 2 weeks | Not all patients were admitted following the procedure which accounts for the difference in overall number of participants analyzed. A minimum of 3 pain assessments were completed by nursing staff/anesthesia during admission: Anesthesia/ PACU- initial pain assessment Evening-2100- pain assessment by RN Morning -0800- pain assessment by RN We defined \*Pain score \> 0 (any pain) for patients in the rectal indomethacin vs. IV ketorolac cohorts using the NRS and FLACC Pain scale. 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 |
| Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning | 2 weeks | Not all patients were admitted following the procedure which accounts for the difference in overall number of participants analyzed. A minimum of 3 pain assessments were completed by nursing staff/anesthesia during admission: Anesthesia/ PACU- initial pain assessment Evening-2100- pain assessment by RN Morning -0800- pain assessment by RN We defined \*Pain score \> 0 (any pain) for patients in the rectal indomethacin vs. IV ketorolac cohorts using the NRS and FLACC Pain scale. 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 |
| Laboratory Markers Associated With PEP ( Lipase) | 2 weeks | Lipase (unit/L) |
| Laboratory Markers Associated With PEP (Amylase) | 2 weeks | Amylase value in unit/L |
| Length of Stay | 2 weeks | Below is the median length of stay for participants within the rectal indomethacin and IV ketorolac cohorts. The difference in participants analyzed is due to the fact that not all participants were admitted following the procedure. |
| Severity of Pancreatitis (Mild, Moderately Severe, Severe) | 2 weeks | 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 (please see definition 9) that persists \>48 hours. Persistent organ failure may be single or multiple, and may develop beyond the first 48 hours of presentation." |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Vitale, MD
Children's Hospital Medical Center, Cincinnati
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 12.8 years STANDARD_DEVIATION 3.8 |
| Race/Ethnicity, Customized Race Black/African American | 2 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 182 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 96 |
| other Total, other adverse events | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 |
Outcome results
None listed