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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Ochsner Health System.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Usha Ramadhyani, Ochsner Health System Identifier:
First received: October 21, 2008
Last updated: March 14, 2013
Last verified: March 2013
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

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 ]

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

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.


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

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
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 identifier: NCT00778063

Contact: Heather S Porter 504-842-4812

United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Heather S Porter    504-842-4812   
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
Principal Investigator: Usha Ramadhyani, MD Ochsner Health System
Study Director: Dominic S Carollo, MD Ochsner Health System
  More Information

Additional Information:

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

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

Additional relevant MeSH terms:
Otitis Media
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General processed this record on May 22, 2017