Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants

NCT00419601 ↗

Phase 3 Completed 24 enrolled University of Cologne GlaxoSmithKline · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

It shall be investigated whether ventilated neonates and infants with a remifentanyl based analgesia and sedation can be extubated faster after discontinuation of the opioid infusion compared to neonates and infants with a fentanyl based analgesia and sedation.

Timeline

Start: 2006-11
Primary completion: 2010-04
Completion: 2010-04

Outcome

Met primary endpoint

paper Although this was designed as a pilot study, median extubation time was significantly shorter in the remifentanil group (80.0 min, IQR = 15.0-165.0) compared to the fentanyl group (782.5 min, IQR = 250.8-1,875.0) (p = 0.005). PMID 22456770 ↗

Publications

Welzing L, Oberthuer A, Junghaenel S, Harnischmacher U, Stutzer H, Roth B. Remifentanil/midazolam versus fentanyl/midazolam for analgesia and sedation of mechanically ventilated neonates and young infants: a randomized controlled trial. Intensive Care Med. 2012 Jun;38(6):1017-24. doi: 10.1007/s00134-012-2532-1. Epub 2012 Mar 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fentanyl	Other / unclassified	3 ug/kg	—
Subject	Remifentanil	Small molecule	9 ug/kg	—

Indications

No indication recorded.