drugset / Trial / NCT00135668
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Phase 2
Completed
211 enrolled
The Emmes Company, LLC
Duke University · collabStanford University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children. The purpose of this study is to determine the efficacy and safety of sodium nitroprusside in children who will be having surgery, and who require blood pressure lowering in order to decrease the amount of blood loss during their surgery.
Timeline
- Start
- 2005-08
- Primary completion
- 2008-03
- Completion
- 2009-02
Publications
- Drover DR, Hammer GB, Barrett JS, Cohane CA, Reece T, Zajicek A, Schulman SR. Evaluation of sodium nitroprusside for controlled hypotension in children during surgery. Front Pharmacol. 2015 Jul 6;6:136. doi: 10.3389/fphar.2015.00136. eCollection 2015.
- Hammer GB, Connolly SG, Schulman SR, Lewandowski A, Cohane C, Reece TL, Anand R, Mitchell J, Drover DR. Sodium nitroprusside is not associated with metabolic acidosis during intraoperative infusion in children. BMC Anesthesiol. 2013 Apr 30;13:9. doi: 10.1186/1471-2253-13-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | nitroprusside | Other / unclassified | 0.3 ug/kg | Intravenous |
| Comparator | nitroprusside | Other / unclassified | 1 ug/kg | Intravenous |
| Comparator | nitroprusside | Other / unclassified | 2 ug/kg | Intravenous |
| Comparator | nitroprusside | Other / unclassified | 3 ug/kg | Intravenous |