KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Completed

• Conditions: Emergence Delirium; Strabismus
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03779282
• Lead Sponsor: Ochsner Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-15
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-15
• Status Verified: 2018-12
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-17
• Last Update Submitted: 2018-12-17
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria

• anything not meeting the above

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study	Dexmedetomidine	pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
discharge time	up to 24 hours	time the patient is actually discharged from recovery room
wong-baker or numeric pain scores, depending on age	up to 6 hours in recovery room	A low total score would indicate less pain

Trial Locations

Locations (1)

Ochsner Main Campus; 🇺🇸 Jefferson, Louisiana, United States