Comparison · NCT05664074-c3ee47de
Rectal Indomethacin vs IV Ketorolac: Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Rectal Indomethacin vs IV Ketorolac: Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening. Trial comparisons, record NCT05664074-c3ee47de. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05664074-c3ee47de
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.265 | 0.182 | 0.369 | wilson | |
| Risk in group 2 | 0.303 | 0.211 | 0.413 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0376 | -0.176 | 0.101 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.876 | 0.534 | 1.44 | log | |
| Odds ratio, group 1 over group 2 | 0.831 | 0.417 | 1.66 | log | |
| Number needed to treat, for one fewer participant with the outcome on Rectal Indomethacin than on IV Ketorolac | 26.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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 | 22 | 83 | OG000 |
| Group 2 | 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) | 23 | 76 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening
- Description
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
- Time frame
- 2 weeks
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- Rectal Indomethacin vs Intravenous Ketorolac
- NCT number
- NCT05664074
- Phases
- PHASE4
- Conditions
- Post-ERCP Acute Pancreatitis
- Interventions
- Rectal indomethacin, IV ketorolac
- Lead sponsor
- David Vitale MD
- Results first posted
- 2026-03-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05664074?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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