drugset / Trial / NCT00878345
Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation
Withdrawn
Washington University School of Medicine
RandomizedParallel-groupSingle-blindOther
Summary
The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. These protocols are both routinely used for sedation in our unit. The investigators propose to study these two protocols in children ages 6 months to 6 years presenting to the ambulatory procedure center for non-painful procedural sedation. The investigators will compare failure of sedation, side effect profile, recovery and discharge times between the two pharmacologic protocols.
Timeline
- Start
- 2009-11
- Primary completion
- 2010-06
- Completion
- 2010-06
Publications
- Background Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth. 2008 May;18(5):393-402. doi: 10.1111/j.1460-9592.2008.02451.x. Epub 2008 Mar 18.
- Background Mukhtar AM, Obayah EM, Hassona AM. Preliminary experience with dexmedetomidine in pediatric anesthesia. Anesth Analg. 2006 Jul;103(1):250. doi: 10.1213/01.ANE.0000228303.92422.73. No abstract available.
- Background Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents. doi: 10.1213/01.ANE.0000219592.82598.AA.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexmedetomidine | Other / unclassified | 1 ug/kg | Intravenous |
| Comparator | Pentobarbital | Small molecule | 1.25 mg/kg | Intravenous |
| Comparator | Midazolam | Small molecule | 0.05 mg/kg | Intravenous |
| Comparator | Midazolam | Small molecule | 0.5 mg/kg | Intravenous |
Indications
No indication recorded.