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

This study has been withdrawn prior to enrollment.
(The study was not approved by Hospital's Medical Ethics Committee.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353378
First Posted: May 13, 2011
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rong Hu, Shanghai 9th People's Hospital
  Purpose
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.

Condition Intervention Phase
Delirium Drug: dexmedetomidine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium

Resource links provided by NLM:


Further study details as provided by Rong Hu, Shanghai 9th People's Hospital:

Primary Outcome Measures:
  • post anesthesia emergence delirium scale(PAED scale) [ Time Frame: 2 hours post-surgery ]
    evaluate children's PAED scale score 2 hours post-surgery


Secondary Outcome Measures:
  • 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


Enrollment: 0
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)
Arms Assigned Interventions
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 Name: dexmedetomidine hydrochloride injection

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • preschool children undergoing oral maxillofacial surgery

Exclusion Criteria:

  • mental diseases
  • history of neural system disease
  • sedative medication history
  • anticipated difficult airway
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353378


Locations
China, Shanghai
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai 9th People's Hospital
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
  More Information

Responsible Party: Rong Hu, attending in anesthesiology department, Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier: NCT01353378     History of Changes
Other Study ID Numbers: JYMZK-001
First Submitted: April 21, 2011
First Posted: May 13, 2011
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Rong Hu, Shanghai 9th People's Hospital:
dexmedetomidine
emergence delirium
sevoflurane anesthesia
preschool children
oral maxillofacial surgery

Additional relevant MeSH terms:
Delirium
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action