KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
Sponsor
Ochsner Health System (Other)
Overall Status
Completed
CT.gov ID
NCT03779282
Collaborator
(none)
90
1
7
12.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
90 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
Actual Study Start Date
:
Feb 15, 2018
Actual Primary Completion Date
:
Sep 15, 2018
Actual Study Completion Date
:
Sep 15, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| control pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex |
|
| study pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex |
Drug: Dexmedetomidine
see descriptions
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pediatric Anesthesia Emergence Delirium scale scores [up to 6 hours in recovery room]
A low total score would indicate less emergence delirium
Secondary Outcome Measures
- wong-baker or numeric pain scores, depending on age [up to 6 hours in recovery room]
A low total score would indicate less pain
- discharge time [up to 24 hours]
time the patient is actually discharged from recovery room
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- ASA I/II children undergoing outpatient strabismus surgery
Exclusion Criteria:
- anything not meeting the above
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ochsner Main Campus | Jefferson | Louisiana | United States | 70121 |
Sponsors and Collaborators
- Ochsner Health System
Investigators
- Principal Investigator: Khaled Dajani, MD, Ochsner Health System
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Khaled Dajani,
Assistant Professor,
Ochsner Health System
ClinicalTrials.gov Identifier:
NCT03779282
Other Study ID Numbers:
- Pro00014439
First Posted:
Dec 19, 2018
Last Update Posted:
Dec 19, 2018
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: