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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01353378

Enrollment

Registered

2011-05-13

Start date

2011-06-30

Completion date

2011-12-31

Last updated

2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

dexmedetomidine, emergence delirium, sevoflurane anesthesia, preschool children, oral maxillofacial surgery

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.

Interventions

DRUGdexmedetomidine

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.

Study design

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 8 Years

Healthy volunteers

Yes

Inclusion criteria

* preschool children undergoing oral maxillofacial surgery

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
post anesthesia emergence delirium scale(PAED scale)	2 hours post-surgery	evaluate children's PAED scale score 2 hours post-surgery

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026