Trial Outcomes & Findings for Rectal Indomethacin vs Intravenous Ketorolac (NCT NCT05664074)

Rectal Indomethacin vs Intravenous Ketorolac

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

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.

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.

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.

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.

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.

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.

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

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

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

Lipase (unit/L)

Amylase value in unit/L

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 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."