Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium

Delirium Clinical Trial

Official title:

Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01353378
• Other study ID #: JYMZK-001
• Status: Withdrawn
• Phase: Phase 4
• First received: April 21, 2011
• Last updated: May 2, 2017
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2017
• Source: Shanghai 9th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• preschool children undergoing oral maxillofacial surgery

Exclusion Criteria:

• mental diseases

• history of neural system disease

• sedative medication history

• anticipated difficult airway

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• dexmedetomidine
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.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 9th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post anesthesia emergence delirium scale(PAED scale)	evaluate children's PAED scale score 2 hours post-surgery	2 hours post-surgery
Secondary	Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale)	evaluate children's CHEOP scale score 2 hours post-surgery	2 hours post-surgery