Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients
NCT ID: NCT00778063
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2008-09-30
2013-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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saline
intranasal saline will be given 30 minutes prior to surgery
saline
a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery
dexmedetomidine
2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery
dexmedetomidine
2 mcg/kg intranasally 30 minutes prior to surgery
Interventions
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dexmedetomidine
2 mcg/kg intranasally 30 minutes prior to surgery
saline
a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Parental willingness to participate
* Candidate for pressure-equalization tubes (PET) as determined by the ENT department
Exclusion Criteria
* 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
1 Year
5 Years
ALL
Yes
Sponsors
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Ochsner Health System
OTHER
Responsible Party
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Principal Investigators
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Usha Ramadhyani, MD
Role: PRINCIPAL_INVESTIGATOR
Ochsner Health System
Dominic S Carollo, MD
Role: STUDY_DIRECTOR
Ochsner Health System
Locations
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Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Countries
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References
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Olympio MA. Postanesthetic delirium: historical perspectives. J Clin Anesth. 1991 Jan-Feb;3(1):60-3. doi: 10.1016/0952-8180(91)90209-6.
Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. doi: 10.1213/01.ane.0000250914.91881.a8.
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. doi: 10.1046/j.1460-9592.2000.00560.x.
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. doi: 10.1213/01.ane.0000216293.16613.15.
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. doi: 10.1111/j.1460-9592.2005.01660.x.
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. doi: 10.1213/01.ane.0000269488.06546.7c.
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. doi: 10.1213/ane.0b013e31816c8929.
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):321-326. doi: 10.1213/01.ANE.0000096004.96603.08.
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. doi: 10.1093/bja/ael084. 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. doi: 10.1213/00000539-199207000-00010.
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. doi: 10.1111/j.1460-9592.2004.01541.x.
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. doi: 10.1007/BF03008227.
Other Identifiers
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2008.135.C
Identifier Type: -
Identifier Source: org_study_id
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