Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 1 - 10 |
| Updated: | 7/11/2018 |
| Start Date: | January 4, 2011 |
| End Date: | October 8, 2013 |
The Effect of Intramuscular Dexmedetomidine on Emergence Agitation in Children Undergoing With or Without Tube Insertion Under General Anesthesia
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).
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).
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.
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.
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
We found this trial at
1
site
Iowa City, Iowa 52242
Principal Investigator: Martin Mueller, M.D.
Phone: 319-356-7471
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