KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Ketamine

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.

Intervention / Treatment

  • Dexmedetomidine (DRUG)
    see descriptions

Condition or Disease

  • Emergence Delirium
  • Strabismus

Phase

Study Design

Study type: OBSERVATIONAL
Status: Completed
Study results: No Results Available
Age: up to 18 Years   (Child, Adult)
Enrollment: 90 (ACTUAL)
Funded by: Other
Time Perspective: Prospective
Observational Model: Case-Control

Masking

Clinical Trial Dates

Start date: Feb 15, 2018 ACTUAL
Primary Completion: Sep 15, 2018 ACTUAL
Completion Date: Sep 15, 2018 ACTUAL
Study First Posted: Dec 19, 2018 ACTUAL
Results First Posted: Aug 31, 2020
Last Updated: Dec 17, 2018

Sponsors / Collaborators

Lead Sponsor: Ochsner Health System
Responsible Party: N/A

Location

Jefferson, Louisiana, USA

Participant Groups

  • pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex

  • pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex

Eligibility Criteria

Sex: All
Maximum Age: 18
Age Groups: Child / Adult
Healthy Volunteers: Yes

Inclusion Criteria:

* ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria:

* anything not meeting the above

Primary Outcomes

  • A low total score would indicate less emergence delirium

Secondary Outcomes

  • A low total score would indicate less pain

  • time the patient is actually discharged from recovery room

More Details

NCT Number: NCT03779282
Other IDs: Pro00014439
Study URL: https://clinicaltrials.gov/study/NCT03779282
Last updated: Sep 29, 2023