Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

Phase 4 Completed 101 enrolled Children's National Research Institute Hospira, now a wholly owned subsidiary of Pfizer · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary purpose of this study is: 1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia. 2. To determine an analgesic dose response relationship for dexmedetomidine. 3. Compare recovery characteristics of dexmedetomidine to fentanyl.

Timeline

Start: 2005-01
Primary completion: 2008-10
Completion: 2008-10

Outcome

Met primary endpoint

paper During the postoperative period, dexmedetomidine (2 and 4 μg·kg(-1) groups combined) significantly prolonged the opioid-free interval of children who underwent tonsillectomy compared with fentanyl (1 and 2 μg·kg(-1) groups combined) (P < 0.001). PMID 21461792 ↗

Publications

Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	2 ug/kg	Intravenous
Subject	Dexmedetomidine	Other / unclassified	4 ug/kg	Intravenous
Comparator	Fentanyl	Other / unclassified	1 ug/kg	Intravenous
Comparator	Fentanyl	Other / unclassified	2 ug/kg	Intravenous