Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Phase 3 Completed 160 enrolled Federal University of São Paulo Albert B. Sabin Vaccine Institute · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.

Timeline

Start: 2006-01
Primary completion: 2008-07
Completion: 2008-07

Publications

Alencar AJ, Sanudo A, Sampaio VM, Gois RP, Benevides FA, Guinsburg R. Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Jan;97(1):F24-9. doi: 10.1136/adc.2010.203851. Epub 2011 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fentanyl	Other / unclassified	1 ug/kg	Intravenous
Comparator	Fentanyl	Other / unclassified	2 ug/kg	Intravenous
Subject	Tramadol	Other / unclassified	0.1 mg/kg	Intravenous
Subject	Tramadol	Other / unclassified	0.2 mg/kg	Intravenous

Indications

No indication recorded.