The Effect of Intramuscular Dexmedetomidine on Emergence Agitation in Children Undergoing With or Without Tube Insertion Under General Anesthesia

• Participant's Severity of Emergent Agitation (EA) using the Pediatric Anesthesia Emergence Delirium (PAED) scale in PACU (Post-Op Area). [ Time Frame: Participants will be followed for the duration of first PACU recovery step, an expected average visit of 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia. ] [ Designated as safety issue: Yes ]

  The aim/measurement of the study is to determine wheather or not a single IM injection of Dexmedetomidine will reduce the severity of EA in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia.

  PAED scale measurements that will be observed/recorded are:

  The child makes eye contact with the caregiver, purposeful actions, aware of surroundings, restless & inconsolable.

  These observations will be assessed 1 time during the child's worse episode of agitation & given a score from 0-4. Scores will be added together to determine degree of ED in child.

  
  

• Participant's Severity of Emergent Agitation (EA) in PACU (Post-Op Area) through Day 3 Post-Op using the Postanesthesia Discharge Scoring System (PADSS) score. [ Time Frame: Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia. ] [ Designated as safety issue: Yes ]
  Duration of stay in the PACU (Post-Op Area) until discharge criteria are met based on modified PADSS score: level of consciousness, physical activity, hemodynamic stability, respiratory stability, oxygen saturation status, post-operative pain, and post-operative emetic symptoms. Duration of time will be measured in total mintues participate is in PACU until discharged.
  
  
• Participant's Severity of Emergent Agitation (EA) in PACU (Post-Op Area) through Day 3 Post-Op using the PADSS score. [ Time Frame: Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff. ] [ Designated as safety issue: Yes ]
  Postoperative adverse respiratory events: moderate to severe coughing, oxygen desaturation (SPO2 <90%), breath holding, bronchospasm, aspiration, stridor and/or laryngospasm during PACU duration to discharge. The adverse respiratory events and the adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered. Measurement will be obtained by "yes"/"no" to each possible adverse respiratory event by anesthesia staff.
  
  
• Participant's Severity of Emergent Agitation (EA) in PACU (Post-Op Area) through Day 3 Post-Op using the PADSS score. [ Time Frame: Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff. ] [ Designated as safety issue: Yes ]
  Postoperative adverse hemodynamic events: bradycardia-a decrease in heart rate, hypotension-a decrease in systolic blood pressure (both determined as a 30% decrease from baseline) during PACU duration to discharge. The adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered.Measurement will be obtained by "yes"/"no" to each possible adverse respiratory event by anesthesia staff.
  
  
• Participant's Severity of Emergent Agitation (EA) in PACU (Post-Op Area) through Day 3 Post-Op using the Postanesthesia Discharge Scoring System (PADSS) score. [ Time Frame: Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff. ] [ Designated as safety issue: Yes ]
  Postoperative behavioral disturbances are: sleep disturbances, anxiety, eating disturbances. Data regarding postoperative behavioral disturbances will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by "yes"/"no" to each possible AE by staff based on parent(s) response.
  
  
• Participant's Severity of Emergent Agitation (EA) in PACU (Post-Op Area) through Day 3 Post-Op using the Postanesthesia Discharge Scoring System (PADSS) score. [ Time Frame: Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff. ] [ Designated as safety issue: Yes ]
  Postoperative muscle pain or swelling at the drug injection site. The duration of the stay in the PACU will be retrospectively documented by the research team using EPIC. Data regarding postoperative muscle pain or swelling will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by "yes"/"no" by staff based on parent(s) response.
  
  

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.