We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients (PED-DEX)

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.
ClinicalTrials.gov Identifier: NCT00778063
Recruitment Status : Unknown
Verified March 2013 by Usha Ramadhyani, Ochsner Health System.
Recruitment status was:  Recruiting
First Posted : October 23, 2008
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium during general sevoflurane anesthesia in a pediatric population receiving pressure equalization tubes in one or more ear.

Condition or disease Intervention/treatment
Otitis Media Drug: dexmedetomidine Drug: saline

Detailed Description:

Emergence delirium has been described as a dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent, inconsolably crying, moaning, kicking or thrashing. The children can run the gambit from restlessness and incoherence to combative and psychotic. The incidence of emergence agitation or delirium is 80% after a procedure with sevoflurane-induced anesthesia.

Dexmedetomidine has been shown to have sedative and analgesic effects. In the pediatric population, it has been shown to provide sedation for radiographic procedures. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intranasally might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing myringotomy and tube placement.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intranasal Dexmedetomidine Decreases Emergence Delirium in Pediatric Patients After Sevoflurane Based General Anesthesia
Study Start Date : March 2009
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Delirium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: saline
intranasal saline will be given 30 minutes prior to surgery
Drug: saline
a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery
Experimental: dexmedetomidine
2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery
Drug: dexmedetomidine
2 mcg/kg intranasally 30 minutes prior to surgery
Other Name: Precedex


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia. [ Time Frame: 2 hours post-surgery ]

Secondary Outcome Measures :
  1. Evaluate post-operative pain, emesis, and time to release from recovery. [ Time Frame: 2 hours post-surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA class 1 or 2 (healthy patient or acute illness)
  • Parental willingness to participate
  • Candidate for pressure-equalization tubes (PET) as determined by the ENT department

Exclusion Criteria:

  • ASA class 3 or 4 (chronic illness or life-threatening illness)
  • Parental refusal to participate
  • Significant liver disease by history
  • Allergy to dexmedetomidine or midazolam
  • Nasal deformity
  • Fever in the three days prior to surgery
  • Nausea or vomiting
  • History of hypertension
  • History of cardiac dysfunction/disorder
  • Diabetes mellitus
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): NCT00778063


Contacts
Contact: Heather S Porter 504-842-4812 hporter@ochsner.org

Locations
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Heather S Porter    504-842-4812    hporter@ochsner.org   
Principal Investigator: Usha Ramadhyani, MD         
Sub-Investigator: Dominic S Carollo, MD         
Sub-Investigator: J L Guarisco, MD         
Sub-Investigator: Kimsey H Rodriguez, MD         
Sponsors and Collaborators
Ochsner Health System
Investigators
Principal Investigator: Usha Ramadhyani, MD Ochsner Health System
Study Director: Dominic S Carollo, MD Ochsner Health System
More Information

Publications:

Responsible Party: Usha Ramadhyani, Anesthesiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT00778063     History of Changes
Other Study ID Numbers: 2008.135.C
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013

Keywords provided by Usha Ramadhyani, Ochsner Health System:
dexmedetomidine
pressure equalization tubes in the ear
myringotomy
sevoflurane

Additional relevant MeSH terms:
Delirium
Otitis Media
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Postoperative Complications
Pathologic Processes
Dexmedetomidine
Sevoflurane
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