Trial intelligence / Profile preview

Rectal Indomethacin vs IV Ketorolac for Post-ERCP Pancreatitis Prophylaxis in Pediatrics

NCT05664074Phase 4

Key facts

Status: Completed
Start: Nov 2022
Primary completion: Feb 2025
Countries: 1
Modality: Small Molecules

Drugs: indomethacinketorolac
Conditions: acute pancreatitis (AP)

Overview

Phase 4, randomised trial in acute pancreatitis (AP) comparing Rectal indomethacin with IV ketorolac (2 arms). Primary endpoints: Post-ERCP Pancreatitis at 2 weeks, Post-ERCP Pancreatitis: Pancreatic Duct Injections at 2 weeks and 5 more. Started Nov 2022; status: completed.

Design

2 arms

Study design: Randomized

Rectal indomethacin
Rectal indomethacin dosed by weight (25 mg to 100 mg)
IV ketorolac
IV ketorolac dosed by weight (0.5 mg/kg, max 15 mg)

Who it enrols

Pediatric patients undergoing ERCP, excluding those weighing <10 kg, at low risk (prior biliary sphincterotomy), high risk for bleeding, with recent GI bleeding, acute pancreatitis, peptic ulcer disease, kidney disease, or using NSAIDs/Lithium.

Endpoints

Primary

Post-ERCP Pancreatitis2 weeks
Post-ERCP Pancreatitis: Pancreatic Duct Injections2 weeks
Post-ERCP Pancreatitis: Native Papilla2 weeks
Post-ERCP Pancreatitis: Pancreatic Sphincterotomy2 weeks
Post-ERCP Pancreatitis: Opti-Ray Amount2 weeks

Secondary

Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU2 weeks
Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening2 weeks
Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning2 weeks
Laboratory Markers Associated With PEP (Lipase)2 weeks
Laboratory Markers Associated With PEP (Amylase)2 weeks
Length of Stay2 weeks
Severity of Pancreatitis2 weeks

Beyond the preview

Go deeper on NCT05664074.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05664074.