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

October 21, 2008
March 14, 2013
March 2009
March 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00778063 on ClinicalTrials.gov Archive Site
Evaluate post-operative pain, emesis, and time to release from recovery. [ Time Frame: 2 hours post-surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients
Intranasal Dexmedetomidine Decreases Emergence Delirium in Pediatric Patients After Sevoflurane Based General Anesthesia

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Otitis Media
  • Drug: dexmedetomidine
    2 mcg/kg intranasally 30 minutes prior to surgery
    Other Name: Precedex
  • Drug: saline
    a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery
  • Placebo Comparator: saline
    intranasal saline will be given 30 minutes prior to surgery
    Intervention: Drug: saline
  • Experimental: dexmedetomidine
    2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery
    Intervention: Drug: dexmedetomidine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
1 Year to 5 Years
Yes
Contact: Heather S Porter 504-842-4812 hporter@ochsner.org
United States
 
NCT00778063
2008.135.C
Yes
Usha Ramadhyani, Ochsner Health System
Ochsner Health System
Not Provided
Principal Investigator: Usha Ramadhyani, MD Ochsner Health System
Study Director: Dominic S Carollo, MD Ochsner Health System
Ochsner Health System
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP