Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children
Condition: Agitation; Anesthesia; Pediatrics
MeSH terms: Delirium; Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 3

Summary: 
      Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population
      undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine
      versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical
      population.
    

Detailed description: 
      Emergence delirium from general anesthesia is a common problem in the pediatric population
      with a reported incidence of up to 80%. In addition to being jarring to children and their
      parents, ED can cause significant physical harm, particularly to the surgical site. ED is
      also associated with accidental removal of surgical dressings and drains, intravenous and
      intra-arterial catheters, increased nursing care, extended recovery room stays, and delayed
      reunion with parents. Emergence delirium is especially associated with sevoflurane, the most
      commonly used inhalation anesthetic in pediatrics. At present, there is no single definition
      of pediatric ED because of its heterogeneous clinical presentation. It has been described as
      an acute phenomenon in which the child is irritable, uncompromising, uncooperative,
      incoherent, and inconsolably crying, moaning, kicking or thrashing. Typically, these children
      do not recognize or identify familiar objects or people, and often exhibit combative
      behavior. Although ED is a self-limiting phenomenon, it is especially dangerous in the
      interventional neuroradiologic patient whose femoral artery has been catheterized and must be
      kept immobile in the immediate post-operative period. These patients also have multiple
      intravenous and intra-arterial catheters which can be dislodged during an episode of ED.
      Numerous pharmacologic agents including benzodiazepines, opioids, ketamine, and clonidine,
      have been studied as prophylactic agents for ED but have met with varying success. Promising
      results with the α-2 adrenergic agonist clonidine, have spurred interest in a new α-2
      adrenergic agonist, dexmedetomidine.

      Dexmedetomidine is highly selective for the 2A subtype of the central presynaptic α-2
      adrenergic receptor which is associated with sedation and analgesia. It is currently approved
      for use in adults as a sedative agent in intensive care units but has been used in myriad
      other ways for sedation. As a sedative, dexmedetomidine is unusual in that it does not
      depress respiratory drive because its actions are not mediated by the GABA-mimetic system.
      The quality of sedation produced by dexmedetomidine is unique, and has been described as
      "cooperative sedation," in which patients can interact with healthcare providers and follow
      verbal commands. This particular sedation profile permits a patient to be comfortably
      sedated, yet cooperate for an accurate neurological exam. The most extreme example of this is
      the awake craniotomy, in which a patient undergoes a neurological examination during surgery.
      In addition to being sedative, dexmedetomidine is also analgesic and suppresses shivering,
      making it especially useful in the perioperative period.

      There have been studies suggesting a use for dexmedetomidine in ED yet none have examined its
      use in the pediatric neurosurgical population. Treatment of ED in pediatric neurosurgical
      patients involves balancing the need for smooth emergence with the need for accurate
      neurological exams. Benzodiazepines and opioids are currently used to treat ED but are
      long-acting, interfere with neurological exams, and carry the risks of respiratory
      depression, nausea, vomiting, and acute tolerance. Dexmedetomidine provides an alternative to
      current treatment modalities for ED, which does not interfere with neurological exams.
    

Intervention name(s): Dexmedetomidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine will be dissolved in saline. An initial loading dose of 1.0 mg/kg given over 10 minutes followed by a continuous infusion at 0.4-0.7 mg/kg/hour. Beginning approximately one hour prior to end of surgery and continuing for one hour of recovery in the PACU and the PICU. This, the maximum dose for any one patient will be 2.4 mg/kg; Given by a continuous infusion
Other intervention name(s): Precedex; Phosphate buffered saline; PBS
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Emergence Delirium; Agitation; Pediatric; Anesthesia