CARE--Childhood Awareness and Recall Evaluation
Condition: Anesthesia
Study type: Observational

Summary: 
      The purpose of this study is to describe the incidence of recall or awareness under
      anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data
      relating to intra-operative recall during general anesthesia.

      The hypothesis is that the implementation of routine awareness follow-up evaluation in
      children undergoing general anesthesia will identify that the incidence of intra-operative
      awareness in children is equal to or greater than in adults.
    

Detailed description: 
      Awareness, or the unwanted recall of intra-operative events occurring during general
      anesthesia, is a potentially avoidable anesthetic complication that poses the risk for
      psychological sequelae. While the reported incidence is 0.1-0.2% in adults, this translates
      to > 20,000 cases of awareness occurring in adults annually in the United States (Ekman,
      2004; Myles, 2000; Sandin, 2000; Sebel, 2004; Myles, 2004). Patients who experience recall
      may subsequently exhibit post-traumatic stress and psychological symptoms (Sebel, 2004;
      Myles, 2004; Moerman, 1993; Lennmarken, 2002). Furthermore; studies have shown that up to 54%
      of adult patients worry about the possibility of awareness during surgery (Klafta, 1996).
      Subsequent to the recent studies on unintended intraoperative awareness and published data on
      the impact of Bispectral Index in preventing and detecting anesthesia awareness, the Joint
      Commission on Accreditation of Healthcare Organizations has classified intraoperative
      awareness as a sentinel event (2004).

      Limited data are available regarding the incidence and consequences of awareness in children.
      Studies which are available have identified a significantly higher incidence of
      intraoperative recall in children than has been shown in adults. McKie reported an incidence
      of 5% factual recall in 202 patients aged 7-14 years in 1973 (1973). The incidence of
      dreaming was reported as 11%. Hobbs, in 1988, reported a 19% incidence of dreaming and no
      awareness in 120 pediatric patients who received the "Liverpool anesthetic technique" (N20,
      O2, relaxant). Ranta reported 0.4% awareness in 4800 patients aged 12 years or older, with
      the youngest patient demonstrating undisputed awareness at 20 years of age (1998). More
      recently, Lopez et. al., found an 8% incidence of awareness in children 6-16 years of age,
      with a significant relationship between multiple attempts to secure the airway and the
      likelihood of awareness (2004). Most recently, a study published in 2005 by Davidson, et.
      al., found an incidence of 0.8% in 864 children aged 5-12 years of age with general
      anesthesia as is practiced in Australia. Likely explanations for more frequent awareness in
      children include altered anesthetic pharmacology in children and differences in the practice
      of pediatric anesthesia.

      Post-operative behavior changes including emergence delirium, general anxiety, nighttime
      crying, enuresis, separation anxiety and temper tantrums have been described to occur up in
      to 50% of children undergoing surgery (Kain, 1996). Studies have also shown a correlation
      between pre-operative anxiety levels of both the child and parents, and may result in a
      greater risk of emergence delirium and later maladaptive behaviors. These results have not
      demonstrated a cause-effect relationship (Kain, 2004). Evaluating for intra-operative
      awareness or unwanted recall of intra-operative events with or without depth of anesthesia
      monitoring, may add to the knowledge base for causal factors in postoperative maladaptive
      behavior changes in the pediatric population.

      The JCAHO Sentinel Event Alert, Issue 32, dated October 6, 2004, describes recommendations
      for health care organizations which perform procedures under general anesthesia, for the
      prevention and detection of intra-operative awareness. Specific recommendations include:
      identification of patients who are at higher risk for intraoperative awareness, appropriate
      follow-up of all patients, including children, who have undergone general anesthesia, and
      identification, management and, if appropriate, referral of patients who have experienced
      awareness.

      Since little data exists on the incidence and identification of intra-operative awareness in
      children, this multi-center, prospective, observational, cohort evaluation is being conducted
      to describe and evaluate the incidence of awareness during routine general anesthetic
      practice in children. Following IRB approved informed consent (and assent as appropriate),
      children will sequentially be enrolled to participate in the study. Participating
      institutions will share de-identified data of enrolled pediatric patients undergoing general
      anesthesia. Each center will collect and maintain patient data in compliance with all privacy
      and institutional guidelines.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 5-15 years of age scheduled for a surgical procedure that requires general
        anesthesia
      
Keywords: Pediatrics; Intraoperative Awareness; Pediatric Anesthesia