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

May 2, 2017 updated by: Rong Hu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • preschool children undergoing oral maxillofacial surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine
intravenously injecting 0.125microgram/kg and 0.25microgram/kg within 10 minutes as soon as the operation begins respectively.
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.
Other Names:
  • dexmedetomidine hydrochloride injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 13, 2011

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JYMZK-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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