Delirium on Emergence Clinical Trial
Official title:
Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children
Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and
rapid onset and offset of action.The reported incidence of emergence agitation (EA)
following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA
is still considered as a potentially serious complication because of the risks of
self-injury, and because of the stress caused to both caregivers and families.
Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic
actions, has been used in pediatric populations.Several prospective clinical trials in
children have shown that dexmedetomidine significantly reduces the incidence of EA prior to
recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication
on emergence agitation has not been fully evaluated. The purpose of the present study was to
verify the hypothesis that intranasal premedication with dexmedetomidine is effective in
reducing emergence agitation after sevoflurane anaesthesia.
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED)
scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness
of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a
maximum of 20 points.
A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA
score was recorded. Agitation scores < 10 were interpreted as an absence of agitation,
scores>= 10 were regarded as presence of agitation.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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