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This study has been withdrawn prior to enrollment.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 considering dexmedetomidine's indication range.)
Sponsor:
Information provided by:
Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier:
NCT01353378
First received: April 21, 2011
Last updated: August 2, 2011
Last verified: April 2011
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Shanghai 9th People's Hospital:

Primary Outcome Measures:
  • post anesthesia emergence delirium scale(PAED scale) [ Time Frame: 2 hours post-surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    evaluate children's CHEOP scale score 2 hours post-surgery


Estimated Enrollment: 90
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

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hong Jiang, Director of Anesthesiology department , Shanghai 9th People's Hospital affiliated to Shanghai Jiao Tong University, school of Medicine
ClinicalTrials.gov Identifier: NCT01353378     History of Changes
Other Study ID Numbers: JYMZK-001
Study First Received: April 21, 2011
Last Updated: August 2, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 18, 2014