Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients

Otitis Media Clinical Trial

— PED-DEX  

Official title:

Intranasal Dexmedetomidine Decreases Emergence Delirium in Pediatric Patients After Sevoflurane Based General Anesthesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00778063
• Other study ID #: 2008.135.C
• Status: Terminated
• Phase: N/A
• Start date: September 2008
• Est. completion date: March 2013

Study information

• Verified date: April 2023
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Otitis Media

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Olympio MA. Postanesthetic delirium: historical perspectives. J Clin Anesth. 1991 Jan-Feb;3(1):60-3. doi: 10.1016/0952-8180(91)90209-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.0b013e31816c — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia.		2 hours post-surgery
Secondary	Evaluate post-operative pain, emesis, and time to release from recovery.		2 hours post-surgery