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NCT03779282 Clinical Trial

KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Strabismus Clinical Trial

Official title:
KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03779282
Other study ID # Pro00014439
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2018
Est. completion date September 15, 2018

Study information
Verified date December 2018
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date September 15, 2018
Est. primary completion date September 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria:

- anything not meeting the above

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
see descriptions

Locations
Country Name City State
United States Ochsner Main Campus Jefferson Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pediatric Anesthesia Emergence Delirium scale scores A low total score would indicate less emergence delirium up to 6 hours in recovery room
Secondary wong-baker or numeric pain scores, depending on age A low total score would indicate less pain up to 6 hours in recovery room
Secondary discharge time time the patient is actually discharged from recovery room up to 24 hours
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