An interventional study of Midazolam and Game Boy in Pediatric Emergence Agitation and Pain, sponsored by University of Medicine and Dentistry of New Jersey. Completed at 1 site in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2009-07-03.
Sponsored by University of Medicine and Dentistry of New Jersey · Not applicable, Interventional, and Prevention
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 119 is above the median of 70 across 2,101 interventional studies indexed under Pain.
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Exclusion Criteria:
Device: Game Boy
Drug: Midazolam
Midazolam 0.5mg/kg
Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction
Also known as: Nintendo-DS Game Boy
postoperative pain
Time frame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge
emergence agitation
Time frame: on arrival, at 5 minutes and every 10 min for one hour in PACU
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midazolam
University of Medicine and Dentistry of New Jersey →