KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

NCT03779282 | Completed

• 1 other identifier: Pro00014439
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium; Strabismus

Outcome Measures

Primary Outcomes (1)

• Pediatric Anesthesia Emergence Delirium scale scores

  A low total score would indicate less emergence delirium

  up to 6 hours in recovery room

Secondary Outcomes (2)

• wong-baker or numeric pain scores, depending on age

  up to 6 hours in recovery room

• discharge time

  up to 24 hours

Study Arms (2)

control

pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex

study

pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

see descriptions

Also known as: ketamine

study

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children, aged 0-18 years, undergoing outpatient strabismus surgery under general anesthesia

You may qualify if:

• ASA I/II children undergoing outpatient strabismus surgery

You may not qualify if:

• anything not meeting the above

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Main Campus

Jefferson, Louisiana, 70121, United States

Location

Related 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.

  PMID: 25770644 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Strabismus

Interventions

Dexmedetomidine; Ketamine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Ocular Motility Disorders; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Khaled Dajani, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: February 15, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)