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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal indomethacin | Experimental | Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg |
|
| IV ketorolac | Experimental | Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal indomethacin | Drug | Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP Pancreatitis | 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:
| 2 weeks |
| Post-ERCP Pancreatitis: Pancreatic Duct Injections | 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. | 2 weeks |
| Post-ERCP Pancreatitis: Native Papilla | 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. | 2 weeks |
| Post-ERCP Pancreatitis: Pancreatic Sphincterotomy | 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. | 2 weeks |
| Post-ERCP Pancreatitis: Opti-Ray Amount | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU | 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
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Vitale, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rectal Indomethacin | Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg Rectal indomethacin: Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg |
| FG001 | IV Ketorolac | Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) IV ketorolac: Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rectal Indomethacin | Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg Rectal indomethacin: Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg |
| BG001 | IV Ketorolac |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-ERCP Pancreatitis | 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:
| Posted | Count of Participants | Participants | 2 weeks |
|
Adverse events were monitored up to two weeks following the procedure.
Per IRB approved study protocol: "Adverse events (AEs) related to the study procedures will be monitored by the study coordinator and reported to the PI." Only adverse events related to ketorolac v. indomethacin randomization were monitored. No All-Cause Mortality, Serious AEs, or Other AEs occurred due to study medication procedures or randomization.
While post-ERCP pancreatitis was monitored for outcomes, it was excluded as an AE by our protocol as it was not related to study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rectal Indomethacin | Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg Rectal indomethacin: Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Vitale | Cincinnati Children's | (513) 517-7040 | David.Vitale@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2023 | Feb 4, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2022 | Dec 8, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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This will be a prospective study where patients will be randomized into either rectal indomethacin or IV ketorolac.
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| IV ketorolac | Drug | Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) |
|
| 2 weeks |
| Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed | 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. | 2 weeks |
| Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed | 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. | 2 weeks |
| 2 weeks |
| Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening | 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
| 2 weeks |
| Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning | 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
| 2 weeks |
| Laboratory Markers Associated With PEP ( Lipase) | Lipase (unit/L) | 2 weeks |
| Laboratory Markers Associated With PEP (Amylase) | Amylase value in unit/L | 2 weeks |
| Length of Stay | 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. | 2 weeks |
| Severity of Pancreatitis (Mild, Moderately Severe, Severe) | Severity of AP will be classified as mild, moderately severe, or severe in accordance with the NASPGHAN Classification system.
| 2 weeks |
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) IV ketorolac: Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | IV Ketorolac | Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) IV ketorolac: Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) |
|
|
| Primary | Post-ERCP Pancreatitis: Pancreatic Duct Injections | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Primary | Post-ERCP Pancreatitis: Native Papilla | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Primary | Post-ERCP Pancreatitis: Pancreatic Sphincterotomy | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Primary | Post-ERCP Pancreatitis: Opti-Ray Amount | 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. | Amount of Opti-Ray used on patients who developed Post-ERCP pancreatitis | Posted | Median | Inter-Quartile Range | mL | 2 weeks |
|
|
|
| Primary | Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Primary | Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
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| Secondary | Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU | 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
| Number of participants below is the number that experienced any pain (pain score >0) in the PACU | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening | 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
| Number of participants below is the number that experienced any pain (pain score >0) the evening following the procedure. There is a discrepancy in total participant number due to the fact that not all patients were admitted post-op. | Posted | Count of Participants | Participants | 2 weeks |
|
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| Secondary | Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning | 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
| Number of participants below is the number that experienced any pain (pain score >0) the morning (POD1) following the procedure. There is a discrepancy in total participant number due to the fact that not all patients were admitted post-op. | Posted | Count of Participants | Participants | 2 weeks |
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| Secondary | Laboratory Markers Associated With PEP ( Lipase) | Lipase (unit/L) | There is a discrepancy in total participant number due to the fact that not all patients received lipase laps. Lipase was only measured with pain to monitor for possible pancreatitis. | Posted | Median | Inter-Quartile Range | unit/L | 2 weeks |
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| Secondary | Laboratory Markers Associated With PEP (Amylase) | Amylase value in unit/L | There is a discrepancy in total participant number due to the fact that not all patients received amylase laps. Amylase was only measured with pain to monitor for possible pancreatitis. | Posted | Median | Inter-Quartile Range | unit/L | 2 weeks |
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| Secondary | Length of Stay | 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. | Posted | Median | Inter-Quartile Range | days | 2 weeks |
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| Secondary | Severity of Pancreatitis (Mild, Moderately Severe, Severe) | Severity of AP will be classified as mild, moderately severe, or severe in accordance with the NASPGHAN Classification system.
| Below is the number of participants who developed mild, moderate, or severe pain in the rectal indomethacin and IV ketorolac cohorts. Zero patients developed severe pain. | Posted | Count of Participants | Participants | 2 weeks |
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| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | IV Ketorolac | Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) IV ketorolac: Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) | 0 | 96 | 0 | 96 | 0 | 96 |
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| D006571 | Heterocyclic Compounds |
| Severe |
|