Emergence Delirium and Recovery Time in Children

Not Applicable

• Conditions: Emergence Delirium
• Interventions: Diagnostic Test: PAEDS; Procedure: TIVA; Procedure: Inhalational anesthesia

• Registration Number: NCT03330613
• Lead Sponsor: Aydin Adnan Menderes University

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Study Start: 2017-11-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11
• Primary Completion: 2018-07-15
• Study Completion: 2018-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhalational anesthesia	TIVA	Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.
Total intravenous anesthesia	TIVA	Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.
Inhalational anesthesia	Inhalational anesthesia	Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.
Total intravenous anesthesia	Inhalational anesthesia	Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.
Total intravenous anesthesia	PAEDS	Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.
Inhalational anesthesia	PAEDS	Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.

Primary Outcome Measures

Name	Time	Method
Emergence delirium	6 hours	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; 1. The child makes eye contact with the caregiver 4 3 2 1 0; 2. The child's actions are purposeful 4 3 2 1 0; 3. The child is aware of his/her surroundings 4 3 2 1 0; 4. The child is restless 0 1 2 3 4; 5. The child is inconsolable 0 1 2 3 4; The Pediatric Anesthesia Emergence Delirium Scale

Secondary Outcome Measures

Name	Time	Method
Recovery time	6 hours	The period of stay at the post-anesthesia care unit

Trial Locations

Locations (1)

Ozlem Kocaturk; 🇹🇷 Aydin, Turkey