Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia
Completed · Phase 4 · Has a placebo group
Conditions studied: Myringotomy
In brief
The investigators are inviting your child to participate in this research study because your child is having myringotomy (putting a tiny incision in the eardrum with or without tube insertion) under general anesthesia. The purpose of this study is to determine whether a single injection of Dexmedetomidine (study medication) decreases the frequency of awaking from anesthesia frightened or agitated in children having myringotomy surgery as compared to those children who receive placebo (sterile saltwater).
Key facts
- Study ID
- NCT01535287
- Run by
- Martin Mueller
- People needed
- 140
- Starts
- 2011-01-04
- Expected to finish
- 2013-10-08
- Last updated by the study team
- 2018-07-09
Who can join
Age: 1 and older, up to 10. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ASA I or II (American Society of Anesthesiology classification ASA I means patients without systemic disease, ASA II means patients with one controlled systemic medical disease eg: Diabetes, Hypertension.)
- Between the ages of 1 and 10 years
- Undergoing BMT under general anesthesia.
You may not qualify if…
- ASA III or higher (Patients with 2 or more medical systemic disease that is not under control, eg: uncontrolled Diabetes)
- Congenital diseases
- Coagulation disorders
- Known allergic reaction to dexmedetomidine
- Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal, neurological or endocrine functions
- Severe upper airway infection
- Predicted difficult airway
- Preexisting psychiatric disorders
Where it is running
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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