Pediatric Emergence Agitation and Pain Clinical Trial
Official title:
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?
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.
| Status | Completed |
| Enrollment | 119 |
| Est. completion date | July 2007 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 12 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | University Hospital | Newark | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| University of Medicine and Dentistry of New Jersey | Nintendo of North America |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | postoperative pain | on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge | No | |
| Secondary | emergence agitation | on arrival, at 5 minutes and every 10 min for one hour in PACU | No |