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Clinical Trials/NCT00932685
NCT00932685
Completed
Not Applicable

Is Preoperative Distraction With a Hand Held Video Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children as Weel as Emergence Agitation?

University of Medicine and Dentistry of New Jersey1 site in 1 country119 target enrollmentDecember 2005

Overview

Phase
Not Applicable
Intervention
Game Boy
Conditions
Pediatric Emergence Agitation and Pain
Sponsor
University of Medicine and Dentistry of New Jersey
Enrollment
119
Locations
1
Primary Endpoint
postoperative pain
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
July 2007
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • ASA rating of I-II Mask induction of General Anesthesia

Exclusion Criteria

  • Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines

Arms & Interventions

2. Video Game

Intervention: Game Boy

1. Midazolam 0.5mg/kg

Intervention: Midazolam

Outcomes

Primary Outcomes

postoperative pain

Time Frame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge

Secondary Outcomes

  • emergence agitation(on arrival, at 5 minutes and every 10 min for one hour in PACU)

Study Sites (1)

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