Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients - Full Text View

Sponsored by:	Ochsner Health System
Information provided by:	Ochsner Health System
ClinicalTrials.gov Identifier:	NCT00778063

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

MedlinePlus related topics: Anesthesia Ear Infections

Drug Information available for: Sodium chloride Sevoflurane Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Intranasal Dexmedetomidine Decreases Emergence Delirium in Pediatric Patients After Sevoflurane Based General Anesthesia

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:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
saline: Placebo Comparator 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
dexmedetomidine: Experimental 2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery	Drug: dexmedetomidine 2 mcg/kg intranasally 30 minutes prior to surgery

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
New Orleans, Louisiana, United States, 70121

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

Publications of Results:

Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91.

Cravero J, Surgenor S, Whalen K. Emergence agitation in paediatric patients after sevoflurane anaesthesia and no surgery: a comparison with halothane. Paediatr Anaesth. 2000;10(4):419-24.

Mason KP, Zgleszewski SE, Dearden JL, Dumont RS, Pirich MA, Stark CD, D'Angelo P, Macpherson S, Fontaine PJ, Connor L, Zurakowski D. Dexmedetomidine for pediatric sedation for computed tomography imaging studies. Anesth Analg. 2006 Jul;103(1):57-62, table of contents.

Shukry M, Clyde MC, Kalarickal PL, Ramadhyani U. Does dexmedetomidine prevent emergence delirium in children after sevoflurane-based general anesthesia? Paediatr Anaesth. 2005 Dec;15(12):1098-104.

Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80.

Yuen VM, Hui TW, Irwin MG, Yuen MK. A comparison of intranasal dexmedetomidine and oral midazolam for premedication in pediatric anesthesia: a double-blinded randomized controlled trial. Anesth Analg. 2008 Jun;106(6):1715-21.

Weldon BC, Bell M, Craddock T. The effect of caudal analgesia on emergence agitation in children after sevoflurane versus halothane anesthesia. Anesth Analg. 2004 Feb;98(2):321-6, table of contents.

Alhashemi JA, Daghistani MF. Effects of intraoperative i.v. acetaminophen vs i.m. meperidine on post-tonsillectomy pain in children. Br J Anaesth. 2006 Jun;96(6):790-5. Epub 2006 Apr 13.

Weldon BC, Watcha MF, White PF. Oral midazolam in children: effect of time and adjunctive therapy. Anesth Analg. 1992 Jul;75(1):51-5.

Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6.

Meistelman C, Plaud B, Donati F. Rocuronium (ORG 9426) neuromuscular blockade at the adductor muscles of the larynx and adductor pollicis in humans. Can J Anaesth. 1992 Sep;39(7):665-9.

Other Publications:

Olympio MA. Postanesthetic delirium: historical perspectives. J Clin Anesth. 1991 Jan-Feb;3(1):60-3.

Responsible Party:	Ochsner Clinic Foundation ( Dr. Usha Ramadhyani )
Study ID Numbers:	2008.135.C
Study First Received:	October 21, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00778063
Health Authority:	United States: Institutional Review Board

Keywords provided by Ochsner Health System:

dexmedetomidine
pressure equalization tubes in the ear
myringotomy
sevoflurane

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Dexmedetomidine

Ear Diseases
Sevoflurane
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Adrenergic Agonists

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009