KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

NCT ID: NCT03779282

Last Updated: 2018-12-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-15

Study Completion Date

2018-09-15

Brief Summary

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Strabismus surgery for children is a very common procedure, with a high incidence of emergence delerium in the recovery room. A combination of intravenous ketamine/dexmedetomidine, or ketodex, has been previously shown to reduce emergence delerium in children undergoing adenotonsillectomy. Here, we study its application in strabismus surgery.

Detailed Description

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Conditions

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Emergence Delirium Strabismus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control

pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex

No interventions assigned to this group

study

pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex

Dexmedetomidine

Intervention Type DRUG

see descriptions

Interventions

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Dexmedetomidine

see descriptions

Intervention Type DRUG

Other Intervention Names

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ketamine

Eligibility Criteria

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Inclusion Criteria

* ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria

* anything not meeting the above
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ochsner Health System

OTHER

Sponsor Role lead

Responsible Party

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Khaled Dajani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khaled Dajani, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

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Ochsner Main Campus

Jefferson, Louisiana, United States

Site Status

Countries

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United States

References

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Hadi SM, Saleh AJ, Tang YZ, Daoud A, Mei X, Ouyang W. The effect of KETODEX on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane based-anesthesia. Int J Pediatr Otorhinolaryngol. 2015 May;79(5):671-6. doi: 10.1016/j.ijporl.2015.02.012. Epub 2015 Feb 19.

Reference Type BACKGROUND
PMID: 25770644 (View on PubMed)

Other Identifiers

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Pro00014439

Identifier Type: -

Identifier Source: org_study_id