Clinical trial NCT01535287: Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia
Official title: The Effect of Intramuscular Dexmedetomidine on Emergence Agitation in Children Undergoing With or Without Tube Insertion Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myringotomy
Keywords: Dexmedetomidine
Emergence Agitation
Myringotomy
Children
General Anesthesia
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area).
timeFrame: 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.
Secondary outcomes:
measure: Duration of Stay in PACU
timeFrame: Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.
measure: Respiratory Complications Peri-Operative
timeFrame: 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.
measure: Hemodynamic Instability
timeFrame: 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.
measure: Post-Operative Behavioral Disturbances
timeFrame: 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.
measure: Muscle Pain
timeFrame: 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.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa Hospital and Clinics
name: Martin Mueller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: