Trial · NCT05664074

Rectal Indomethacin vs Intravenous Ketorolac

NCT05664074, Phase 4, Completed, David Vitale MD; results first posted 2026-03-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rectal Indomethacin vs Intravenous Ketorolac. Trials, record NCT05664074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05664074

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rectal Indomethacin vs Intravenous Ketorolac
NCT number: NCT05664074
Status: Completed
Phases: Phase 4
Enrollment: 192 participants, actual
Lead sponsor: David Vitale MD
Conditions: Post-ERCP Acute Pancreatitis
Interventions: Rectal indomethacin, IV ketorolac
First posted: 2022-12-23
Last updated: 2026-03-12
Results first posted: 2026-03-12

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Post-ERCP Pancreatitis	2 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Post-ERCP Pancreatitis: Pancreatic Duct Injections	2 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Post-ERCP Pancreatitis: Native Papilla	2 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Post-ERCP Pancreatitis: Pancreatic Sphincterotomy	2 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Post-ERCP Pancreatitis: Opti-Ray Amount	2 weeks	Amount of Opti-Ray used on patients who developed Post-ERCP pancreatitis	mL	MEDIAN
PRIMARY	Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed	2 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed	2 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU	2 weeks	Number of participants below is the number that experienced any pain (pain score \>0) in the PACU	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening	2 weeks	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning	2 weeks	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.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Post-ERCP Pancreatitis	Rectal Indomethacin		15	Participants
Post-ERCP Pancreatitis	IV Ketorolac		21	Participants
Post-ERCP Pancreatitis: Pancreatic Duct Injections	Rectal Indomethacin	Post-ERCP Pancreatitis	14	Participants
Post-ERCP Pancreatitis: Pancreatic Duct Injections	IV Ketorolac	Post-ERCP Pancreatitis	19	Participants
Post-ERCP Pancreatitis: Pancreatic Duct Injections	Rectal Indomethacin	No Post-ERCP Pancreatitis	72	Participants
Post-ERCP Pancreatitis: Pancreatic Duct Injections	IV Ketorolac	No Post-ERCP Pancreatitis	64	Participants
Post-ERCP Pancreatitis: Native Papilla	Rectal Indomethacin	Post-ERCP Pancreatitis	11	Participants
Post-ERCP Pancreatitis: Native Papilla	IV Ketorolac	Post-ERCP Pancreatitis	15	Participants
Post-ERCP Pancreatitis: Native Papilla	Rectal Indomethacin	No Post-ERCP Pancreatitis	25	Participants
Post-ERCP Pancreatitis: Native Papilla	IV Ketorolac	No Post-ERCP Pancreatitis	18	Participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rectal Indomethacin	96
Overall Study	STARTED	IV Ketorolac	96
Overall Study	COMPLETED	Rectal Indomethacin	96
Overall Study	COMPLETED	IV Ketorolac	96
Overall Study	NOT COMPLETED	Rectal Indomethacin	0
Overall Study	NOT COMPLETED	IV Ketorolac	0

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Rectal Indomethacin	96
Total, all-cause mortality	IV Ketorolac	96
Total, other adverse events	Rectal Indomethacin	96
Total, other adverse events	IV Ketorolac	96
Total, serious adverse events	Rectal Indomethacin	96
Total, serious adverse events	IV Ketorolac	96

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rectal Indomethacin vs IV Ketorolac: Post-ERCP Pancreatitis	Trial comparisons
Rectal Indomethacin vs IV Ketorolac: Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning	Trial comparisons
Rectal Indomethacin vs IV Ketorolac: Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening	Trial comparisons
Rectal Indomethacin vs IV Ketorolac: Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU	Trial comparisons
Rectal Indomethacin vs IV Ketorolac: deaths from any cause	Trial comparisons
Rectal Indomethacin vs IV Ketorolac: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05664074

GET https://conductscience.org/api/trials/v1/NCT05664074/results?page=2

API reference For AI assistants