Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients

Not Applicable

Terminated

• Conditions: Otitis Media
• Interventions: Drug: saline; Drug: dexmedetomidine

• Registration Number: NCT00778063
• Lead Sponsor: Ochsner Health System

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.

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-23
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	saline	intranasal saline will be given 30 minutes prior to surgery
dexmedetomidine	dexmedetomidine	2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery

Primary Outcome Measures

Name	Time	Method
To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia.	2 hours post-surgery

Secondary Outcome Measures

Name	Time	Method
Evaluate post-operative pain, emesis, and time to release from recovery.	2 hours post-surgery

Trial Locations

Locations (1)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States