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

Ochsner Health System

Status: Terminated

Conditions: Otitis Media

Treatments: Drug: dexmedetomidine; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00778063

2008.135.C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

saline

Placebo Comparator group

Description:

intranasal saline will be given 30 minutes prior to surgery

Treatment:

Drug: saline

dexmedetomidine

Experimental group

Description:

2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery

Treatment:

Drug: dexmedetomidine