Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium|
- post anesthesia emergence delirium scale(PAED scale) [ Time Frame: 2 hours post-surgery ] [ Designated as safety issue: No ]evaluate children's PAED scale score 2 hours post-surgery
- Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale) [ Time Frame: 2 hours post-surgery ] [ Designated as safety issue: No ]evaluate children's CHEOP scale score 2 hours post-surgery
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
intravenously injecting 0.125microgram/kg and 0.25microgram/kg within 10 minutes as soon as the operation begins respectively.
Intravenously injecting 0.125microgram/kg for 10ml IV(in the vein)in group 1, 0.25microgram/kg for 10ml in group 2 within 10 minutes as soon as the operation begin. The control group receives 10mlsaline in 10 minutes.
Other Name: dexmedetomidine hydrochloride injection
Emergence delirium is a common side effect of sevoflurane anesthesia in children. Dexmedetomidine, because of its sedative and analgesic properties, might be useful for the management of this adverse effect. In the pediatric population, it has been shown to provide sedation for magnetic resonance imaging. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intravenously might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing oral maxillofacial surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353378
|Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine|
|Shanghai, Shanghai, China, 200011|
|Study Director:||Hong Jiang, MD, PHD||Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine|
|Principal Investigator:||Rong Hu, MD||Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine|