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

Phase 4

Withdrawn

• Conditions: Delirium
• Interventions: Drug: dexmedetomidine

• Registration Number: NCT01353378
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-13
• Study Start: 2011-06
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• preschool children undergoing oral maxillofacial surgery

Exclusion Criteria

• mental diseases
• history of neural system disease
• sedative medication history
• anticipated difficult airway

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	dexmedetomidine	intravenously injecting 0.125microgram/kg and 0.25microgram/kg within 10 minutes as soon as the operation begins respectively.

Primary Outcome Measures

Name	Time	Method
post anesthesia emergence delirium scale(PAED scale)	2 hours post-surgery	evaluate children's PAED scale score 2 hours post-surgery

Secondary Outcome Measures

Name	Time	Method
Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale)	2 hours post-surgery	evaluate children's CHEOP scale score 2 hours post-surgery

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China