Emergence Delirium and Recovery Time in Children

Emergence Delirium Clinical Trial

Official title:

Emergence Delirium and Recovery Time in Children: a Randomized Trial to Compare Total Intravenous Anesthesia With Propofol to Inhalational Sevoflurane Anesthesia for Ambulatory Dental Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03330613
• Other study ID #: 2017/17
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: July 20, 2018

Study information

• Verified date: July 2018
• Source: Adnan Menderes University
• Contact: Ozlem Kocaturk
• Phone: 5367730400
• Email: ozlemoget2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, inhalation anesthesia procedure and intravenous anesthesia method will be compared in terms of emergence delirium and recovery time in children who are scheduled for dental treatment under general anesthesia.

Description:

Pediatric Anesthesia Early Delirium Scale (PAEDS) will be used to evaluate postoperative emergence delirium.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 20, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

1. Indication of dental treatment under general anesthesia.

2. No systemic disease (ASA1).

3. Child and parent agree to participate in the work

Exclusion Criteria:

1. Do not accept to participate in the work.

2. The child is not systemically healthy.

3. Children with allergies to general anesthetic drugs.

4. Contraindicated children to take general anesthesia

5. Children with upper respiratory tract infection on the day of operation

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Diagnostic Test:
• PAEDS
pediatric emergency delirium scale

Procedure:
• TIVA
Total intravenous anesthesia with propofol
• Inhalational anesthesia
Inhalational (volatile) anesthesia with sevoflurane

Locations

Country	Name	City	State
Turkey	Ozlem Kocaturk	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Chandler JR, Myers D, Mehta D, Whyte E, Groberman MK, Montgomery CJ, Ansermino JM. Emergence delirium in children: a randomized trial to compare total intravenous anesthesia with propofol and remifentanil to inhalational sevoflurane anesthesia. Paediatr Anaesth. 2013 Apr;23(4):309-15. doi: 10.1111/pan.12090. — View Citation

König MW, Varughese AM, Brennen KA, Barclay S, Shackleford TM, Samuels PJ, Gorman K, Ellis J, Wang Y, Nick TG. Quality of recovery from two types of general anesthesia for ambulatory dental surgery in children: a double-blind, randomized trial. Paediatr Anaesth. 2009 Aug;19(8):748-55. doi: 10.1111/j.1460-9592.2009.03054.x. Epub 2009 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence delirium	Pediatric Anesthesia Early Delirium Scale (PAED) will be used to assess postoperative agitation.; Point Description Not at all Just a little Quite a bit Very much Extremely; The child makes eye contact with the caregiver 4 3 2 1 0; The child's actions are purposeful 4 3 2 1 0; The child is aware of his/her surroundings 4 3 2 1 0; The child is restless 0 1 2 3 4; The child is inconsolable 0 1 2 3 4; The Pediatric Anesthesia Emergence Delirium Scale	6 hours
Secondary	Recovery time	The period of stay at the post-anesthesia care unit	6 hours