Effect of Animated Cartoon for Prevention of Emergence Agitation in Children Aged 1.5 - 5 yr After General Anesthesia

NCT01880138 | Unknown

• 1 other identifier: 4-2013-0192
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence agitation (EA) in children early after sevoflurane anaesthesia is a common postoperative problem, with incidence ranging up to 80%. Younger patients, particularly in the age range from 1.5 to 5 yr of age, are at increased risk of EA. Preoperative anxiety, as measured by the modified Yale Preoperative Anxiety Scale, has been shown to increase the risk of EA for each increment of 10 points in the child's state anxiety score. So, Alleviates preoperative anxiety in Children maybe decrease the incidence and severity of EA. Preschool children enjoy watching animated cartoons, and they can be immersed to animated cartoon so they become oblivious of their surroundings. Therefore, viewing an animated cartoon maybe reduce preoperative anxiety in children. This study was performed to determine effect of animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr after general anesthesia

Conditions

Sevoflurane Anaesthesia

Keywords

Animated cartoon, Emergence agitation

Outcome Measures

Primary Outcomes (1)

• Pediatric Anesthesia Emergence Delirium (PAED) Scale

  Subjects' behavior was rated in the post-anesthesia care unit (PACU) from the moment subjects opened their eyes, and every 5 minutes until discharge from the PACU. The Pediatric Anesthesia Emergence Delirium (PAED) Scale (Sikich \& Lerman, 2004) was used. The scale assesses 5 behaviors (making eye contact, purposefulness of actions, awareness of surroundings, restlessness, and consolability) on a 5-point scale that ranges from 'not at all' to 'extremely'.

  (PAED) Scale changes from the moment subjects open their eyes, and every 5 minute for 24hours

Study Arms (2)

watching animated cartoon

EXPERIMENTAL

Other: watching animated cartoon before general anesthesia

not watching animated cartoon

PLACEBO COMPARATOR

Other: not watching animated cartoon beofre general anaesthesia

Interventions

watching animated cartoon before general anesthesia OTHER

watching animated cartoon

not watching animated cartoon beofre general anaesthesia OTHER

not watching animated cartoon

Eligibility Criteria

• Age: 17 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. pediatric patient (1.5-5yrs) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia

You may not qualify if:

• \. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

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

Central Study Contacts

Jeong-Rim LEE, MD, PhD

CONTACT

02-2227-3840; MANYA@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

KR (1)