Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia
Condition: Myringotomy
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      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).
    

Detailed description: 
      Emergence agitation (EA) is common in children, especially in the preschool age group who
      undergo general anesthesia. It has been described as a mental disturbance during the recovery
      from general anesthesia and can consist of hallucinations, delusions and confusion in the
      child. To the parent or caregivers this may be seen as moaning, restlessness, involuntary
      physical activity & thrashing about in bed. Emergence agitation (EA) can result in the child
      losing their intravenous therapy (IV) access & bodily injury. Some agitated children may
      retain vivid memories about their negative experience waking up from anesthesia. This can
      result in seeing new behaviors by the child such as anxiety, nighttime crying and temper
      tantrums. Dexmedetomidine given as an injection into the muscle of children is considered
      investigational, which means it hasn't been approved by the U.S. FDA for treatment of this
      problem in children.

      Immediately following surgery measurements of eye contact, purposeful actions, aware of
      surroundings, restless and crying are observed and recorded using the Pediatric Anesthesia
      Emergence Delirium (PAED) scale in PACU.

      Follow-up is made approximately 3 days after surgery by phone call or/and email with
      parent(s) to see if child has experienced any of the following: sleep disturbances, anxiety,
      eating disturbances, postoperative muscle pain or swelling at the injection site.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).
All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Emergence Agitation; Myringotomy; Children; General Anesthesia