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

This study is currently recruiting participants.
Verified March 2013 by Ochsner Health System
Sponsor:
Information provided by (Responsible Party):
Usha Ramadhyani, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT00778063
First received: October 21, 2008
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Otitis Media
 Drug: dexmedetomidine
Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intranasal Dexmedetomidine Decreases Emergence Delirium in Pediatric Patients After Sevoflurane Based General Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia. [ Time Frame: 2 hours post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate post-operative pain, emesis, and time to release from recovery. [ Time Frame: 2 hours post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Click here for more information about this study: The Effects of Pressure Equalization Tubes on Reducing Emergence Delirium  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Usha Ramadhyani, Anesthesiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT00778063     History of Changes
Other Study ID Numbers: 2008.135.C
Study First Received: October 21, 2008
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Delirium
Otitis
Otitis Media
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sevoflurane
Dexmedetomidine
Platelet Aggregation Inhibitors
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists

ClinicalTrials.gov processed this record on June 17, 2013