NCT00778063

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4.5 years

First QC Date

October 21, 2008

Last Update Submit

April 11, 2023

Conditions

Otitis Media

Keywords

dexmedetomidinepressure equalization tubes in the earmyringotomysevoflurane

Outcome Measures

Primary Outcomes (1)

  • To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia.

    2 hours post-surgery

Secondary Outcomes (1)

  • Evaluate post-operative pain, emesis, and time to release from recovery.

    2 hours post-surgery

Study Arms (2)

saline

PLACEBO COMPARATOR

intranasal saline will be given 30 minutes prior to surgery

Drug: saline

dexmedetomidine

EXPERIMENTAL

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

Drug: dexmedetomidine

Interventions

dexmedetomidineDRUG

2 mcg/kg intranasally 30 minutes prior to surgery

Also known as: Precedex
dexmedetomidine
salineDRUG

a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery

saline

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Related Publications (12)

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

    PMID: 2007046BACKGROUND

  • 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.

    PMID: 17179249RESULT

  • 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.

    PMID: 10886700RESULT

  • 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.

    PMID: 16790626RESULT

  • 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.

    PMID: 16324031RESULT

  • 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.

    PMID: 17646493RESULT

  • 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.

    PMID: 18499600RESULT

  • 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.

    PMID: 14742362RESULT

  • 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.

    PMID: 16613928RESULT

  • 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.

    PMID: 1616162RESULT

  • 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.

    PMID: 16101707RESULT

  • 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.

    PMID: 1394754RESULT

MeSH Terms

Conditions

Otitis Media

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Usha Ramadhyani, MD

    Ochsner Health System

    PRINCIPAL INVESTIGATOR

  • Dominic S Carollo, MD

    Ochsner Health System

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 23, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

US(1)